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A RCT of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

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shish-kebab

Even though this study protocol is dated 2013, it’s worth a mention now because the International Society for Nutritional Psychiatry Research just posted this on the ISNPR facebook page.

Recruitment for this important ‘world first’ trial is finally complete (it is hoped that results will be published in late 2015/early 2016)

It’s very exciting! And don’t you just love the name: the “SMILES” trial!

A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

Adrienne O’Neil, Michael Berk, Catherine Itsiopoulos, David Castle, Rachelle Opie, Josephine Pizzinga, Laima Brazionis, Allison Hodge, Cathrine Mihalopoulos, Mary Lou Chatterton, Olivia M Dean and Felice N Jacka.

BMC Psychiatry 2013, 13:114  doi:10.1186/1471-244X-13-114

The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1471-244X/13/114

© 2013 O’Neil et al.; licensee BioMed Central Ltd.

Abstract

Background

Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE).

Methods/Design

One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Asberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention.

Discussion

If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes.

Although the abstract doesn’t mention anxiety, when you read the full study protocol you’ll see these secondary outcomes and aims too:

Secondary outcomes include; depressive and anxiety symptoms, functioning, quality of life, and changes in targeted dietary behaviours, cardiovascular and metabolic risk. A secondary aim is to evaluate the cost efficacy of the intervention from a societal perspective at 3 months.

When I posted this on Facebook, here is a very positive comment I received:

Quote from the article: “A dietary intervention for depression as an adjunct to standard care, has the potential to be cost-effective, highly acceptable and widely applicable. This approach may lead to improved outcomes for individuals with MDE and reduce the public health burden of psychiatric illness.” This is very encouraging, from someone who has suffered from depression my entire life. I’ve had to be my own advocate, especially with the diet connection and finding a way to stay off medications with difficult side effects. Thanks for sharing!

Someone else made a comment about the amount of protein in the study:

17% protein in the study?

This was my response:

Yes it is rather low and the study includes low fat dairy and whole grains too – but it’s a start – it’s a wonderful start!

We can hope that the next step after this one has been published is to do more like this and hopefully have them include more protein (and discuss the quality of the protein), include more full fat dairy and exclude gluten and even one that excludes all grains.

The long term goal will be to dietary interventions as part of the standard of treatment for anxiety, depression and other mental health disorders.

Dr. Felice Jacka talked about this study and the long term goals during our interview on season 1 of the Anxiety Summit: The Research – Food to prevent and treat anxiety and depression?

This is beyond exciting and we so appreciate the researchers and study participants!

How excited are you to see this research being done?

 

Nutritional testing for figuring out the root cause/s of your anxiety

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test

This blog covers the nutritional or functional testing I use with my clients, and what tests I’d run (and/or have my client’s doctor run) if everyone had unlimited funds.

Often it can be challenging to figure out the root cause/s of your anxiety, but that’s where questionnaires, nutritional/ functional/ testing, and a good practitioner (or team of practitioners like nutritionist, functional medicine doctor, nurse practitioner, therapist etc.) comes in – so you can put all the puzzle pieces together.

The following are what I have most of my clients do:

  • The basic blood work that I like to see is a lipid panel, a CBC (complete blood count), a metabolic panel, an iron panel that includes ferritin, and a thyroid panel that includes TSH, free T3, free T4, reverse T3, thyroid antibodies (antithyroglobulin and antithyroperoxidase), vitamin D, and CRP (C-Reactive Protein). There is much we can determine by looking at functional values: digestive status, possible gut dysbiosis, adrenal function, malabsorption, inflammation, as well as low iron, low vitamin D etc. I’ll share more about the markers on this panel of tests in a later blog post.  
  • I also like to see an adrenal saliva test, which measures four times cortisol. So it’d be a saliva collection first thing in the morning, noontime, 5:00 PM, and 10:00 PM. It also shows DHEA; Secretory IgA; and an anti-gliadin antibody (a marker of gluten sensitivity)
  • I rely on the Pyroluria Questionnaire and response to the supplements. The pyroluria urine test is a possibility. But I seldom have clients do it, because we can often see a false negative.
  • For neurotransmitter imbalances – low serotonin, low GABA, low catecholamines and low endorphins – I rely on the Amino Acid Questionnaire and response to amino acids. Vitamin Diagnostics offer a platelet serotonin/dopamine/norepinephrine and epinephrine panel, which is the most accurate way to measure neurotransmitters, if you really wanted to measure them. I don’t ever recommend urinary neurotransmitter testing. It just doesn’t seem to correlate with symptoms.
  • B12 levels. To determine a B12 deficiency, you would want to measure B12, methylmalonic acid (or MMA), and homocysteine.
  • The 23andme genetic testing. This will measure MTHFR, COMT, MAOA, CBS, GAD and many more polymorphisms.

Here is other testing that may be helpful for certain individuals:

  • A sex hormone saliva test. This will measures progesterone, estriol, estrone, estradiol, and testosterone.   I have a wonderful nurse practitioner that I work with, and, if need be, will refer people out to the nurse practitioner if we need support when it comes to bioidentical hormones.
  • A food intolerance test that measures IgG antibodies to 60+ foods. This shows a delayed reaction to the foods.
  • A fatty acid test. This will measure omega-3s (EPA and DHA), omega-6s and omega-9s. And it’ll also measure trans fats. Doing this test is really helpful if you have pyroluria or think that you may have pyroluria.
  • A RBC (red blood cell) magnesium test. Dr. Carolyn Dean talked about the usefulness of this test season 2 of The Anxiety Summit: Take magnesium and melt your anxiety away
  • A stool test. Metametrix/Genova and Diagnostechs offers functional stool testing. It’ll show good bacteria, yeast, parasites, bad bacteria, and digestive markers.
  • A hydrogen breath test or SIBO test. Genova offers this or you can ask your conventional doctor to order this.
  • The H/pylori antigen test. Genova offers this or a conventional doctor can do this.
  • Intestinal permeability profile. Genova offers this.
  • A celiac panel. Genova offers this, or a conventional doctor can do this.
  • The Cyrex panels, which will show gluten and food cross-reactions, and various autoimmune markers.
  • The histamine whole blood is a useful test to see if you have high histamine/histadelia or low histamine/histapenia. This is offered by Vitamin Diagnostics and must be WHOLE blood.
  • Spectracell shows vitamin and mineral deficiencies.
  • A VAP test. If you have concerns about high cholesterol and heart disease, this is going to measure particle size, fibrinogen, Lp(a) and other cardio markers (since looking at only high total cholesterol is not particularly useful).
  • The OAT/Organic Acid Test. Great Plains offers this and it has markers of digestion, yeast overgrowth, infections, B vitamin status and neurotransmitter function.
  • A hair mineral analysis. This is a great way to look for toxic metals and mineral status. You want to look at ratios, not just levels. This is a good marker for copper toxicity as well. Analytical Research Lab offers this test.
  • If you think your copper is too high, or you’ve got low zinc, you can measure copper or ceruloplasmin. This is in serum.
  • Porphyrin testing. This is a measure of the effect of heavy metals such as lead and mecury. Kris Homme talked about this in Season 2 of the Anxiety Summit: Your hidden mercury burden – A likely root cause of the other root causes of anxiety – part 2
  • An amino acid profile, which is a plasma or blood spot test. It’s not something that I use very often, but I have seen people with this test.
  • You can also test candida antibodies in blood, which is not terribly accurate, but sometimes will show up.

I want to look into the following testing:

What functional/nutritional testing have you had done and have found to be helpful? Which of the above tests would you like more detailed information about?

The Anxiety Summit – The Parasite/Anxiety Connection

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Ann Louise Gittleman PhD, CNS, author of The Fat Flush Plan and Guess What Came to Dinner, was interviewed on the Anxiety Summit by host of the Anxiety Summit, Trudy Scott, Food Mood Expert and Nutritionist, author of The Antianxiety Food Solution.

The Parasite/Anxiety Connection

  • How common are parasites and how do we become infected (even if we live in a first world country)
  • How do parasites contribute to anxiety and depression and even schizophrenia
  • Other symptoms of a parasitic infection
  • How to avoid being exposed to parasites
  • How to test for parasites and how do we get rid of the parasite/s

Here are some gems from our interview:

Parasitic infections in the USA are far more common than you would expect – in fact the estimates are that 1 in every 3 people have a parasite or more than one

Parasites can contribute to or cause anxiety and fear by altering “hormonal and neurotransmitter communication and/or direct interference with the neurons and brain regions that mediate behavioural expression”

According to folklore, parasites are more active around the full moon, so testing and treating around this time may yield better results

Toxoplasma gondii is one parasite that has been researched a great deal and is one that has big implications for anxiety and other mood conditions, especially schizophrenia.

Ann Louise shared this interesting article from Scientific American called Toxoplasma’s Dark Side: The Link Between Parasite and Suicide

In 2003, E. Fuller Torrey of the Stanley Medical Research Institute in Bethesda, Maryland his colleagues noted a link between Toxoplasma and schizophrenia – specifically, that women with high levels of the parasite were more likely to give birth to schizophrenics-to-be

scientists have discovered a link between suicide and parasite infection

In 2006, researchers linked Toxoplasma infection to neuroticism in both men and women.

When we are infected with a parasite like Toxoplasma gondii, our immune system goes on the offensive, producing a group of molecules called cytokines that activate various immune cell types. The exact mechanism by which cytokines cause depression and other mental illnesses is poorly understood, but we do know they are able to pass the blood-brain barrier and alter neurotransmitters like serotonin and dopamine in the brain.

Here is the parasite testing and products we discussed:  

The Expanded GI panel (for testing)

Colon Cleaning kit with Verma-Plus and Para- Key (together with a probiotic)

Verma-Plus contains the Native American herb called Centaury (aerial portion) (Centaurium erythraea)

It seems to have antimicrobial properties too: Volatile organic compounds from Centaurium erythraea Rafn (Croatia) and the antimicrobial potential of its essential oil.

And gastroprotective effects: Gastroprotective effect of small centaury (Centaurium erythraea L) on aspirin-induced gastric damage in rats.

We also talked about using filtered water for washing fruits and vegetables and this is the water filter Ann Louise recommends: Countertop Ultra-Ceramic Water Filter. “It purifies your tap water for the removal of incoming contaminants including parasites, chlorine, chloramines, heavy metals, cloudiness and sediment. The ceramic filter also inhibits the growth of bacteria”

Ann Louise has written many wonderful books.  Here are three of them that were mentioned in this interview:

Guess What Came to Dinner? Parasites and Your Health (this is the book about parasites)

Ann Louise Gittleman_guess what came to dinner

 

 

 

 

 

 

 

 

Before the Change: Taking Charge of Your Perimenopause (this is the one that helped me so much when I was in my late thirties and having perimenopausal symptoms – with the zinc, vitamin B6 and evening primrose oil )

Ann Louise Gittleman_before the change

 

 

 

 

 

 

 

 

The Fat Flush Plan (this is one of many her classic weight loss books)

AnnLouiseGittleman_fat flush plan

 

 

 

 

 

 

 

 

Here is her gift: a 50-Page Report on Parasites – Still the Greatest Masqueraders of All Time

If you are not already registered for the Anxiety Summit you can get live access to the speakers of the day here: www.theAnxietySummit.com

Missed this interview or can’t listen live? Or want this and the other great interviews for your learning library? Purchase the MP3s or MP3s + transcripts and listen when it suits you.

You can find your purchasing options here: Anxiety Summit Season 1, Anxiety Summit Season 2, and Anxiety Summit Season 3.

Organic Acids Testing by Great Plains Lab

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greatplainslabThis is a 1-day professional training being held in Berkeley, CA on January 24, 2015: An Overview of Organic Acids Testing and Why it is so Important

Hundreds of organic acid metabolites are found in the urine of all mammals including humans. These metabolites can be used for both diagnostic and therapeutic measurements for: detecting abnormal gastrointestinal overgrowth or dysbiosis, assessing mitochondrial energy production, detecting genetic diseases, assessing malnutrition and suboptimum nutrition, revealing toxic exposure, finding alterations of neurotransmitter metabolites in neurological and psychiatric disorders, and assessing metabolites that cause severe inflammation in a variety of chronic illnesses.

The Interrelationship between Chronic Yeast and Various Issues

The OAT evaluates for various fungal toxins, including specific markers for Candida. Many people rely on stool testing for Candida diagnosis and miss the presence of Candida toxins through the Organic Acid Test. Candida can lead to neurochemical imbalances in the brain, as well as sensory problems and self-stimulatory behavior (often seen in autism).

The Interrelationship between Clostridia and Various Health Issues

The OAT evaluates for two specific toxins related to Clostridia bacteria – HPHPA and 4-cresol. Both of these toxins can inhibit a dopamine converting enzyme, leading to excess dopamine and toxic reactions in the brain and nervous system. Problems such as moodiness, irritability, aggression, self-injurious behavior, sleep difficulties and more can be associated with Clostridia bacteria overgrowth.

Correlating Oxalate Problems

The OAT includes glycolic and glyceric acids in the oxalate section, which can differentiate between genetic and nutritional components in disturbed oxalate metabolism. Oxalates are compounds found in many foods, and can be worsened from Candida overgrowth. High oxalates are associated with pain in the joints, muscles, and connective tissues. They can also trap heavy metals (such as mercury, lead, and arsenic) in the body and lead to mineral imbalances. Certain behavioral issues and self-injurious tendencies have been associated with high oxalates.

Organic Acids Testing and Neurochemical Imbalances

The OAT evaluates for imbalances in serotonin (an important brain chemical for mood, fine and gross motor skills, and calmness), as well additional markers that can indicate toxic stress in the brain and nervous system, such as Quinolinic Acid. High Quinolinic Acid suggests toxic stress in the brain and is important to evaluate before prescribing certain supplements, particularly L-Tryptophan which is commonly used to help with sleep.

Case Studies

This presentation will highlight various patient cases from clinical practice that show the role of biomedical intervention for various patient scenarios such as dietary therapy, yeast and Clostridia treatment, and methylation support.

All of the above, together with start and end times, and breaks can be found here on the presentation schedule page

Presenter: Kurt N. Woeller, D.O., has been an integrative medicine physician and biomedical autism specialist for 15+ years. He is an author of several health books including “Autism – The Road To Recovery,” “Methyl-B12 Therapy For Autism,” “Methyl-B12 for Alzheimer’s Disease and Dementia,” and “5 Things You MUST Do Right Now To Help With Your Rheumatoid Arthritis.” He is a lecturer (United States and International), educator and experienced clinician offering specialized treatment and testing for individuals with complex medical conditions such as Autism-Spectrum Disorders, Chronic Fatigue Syndrome, Mental Health Disorders, Multiple Sclerosis and other chronic health conditions.

I’m sharing this training on behalf of Dr. Kat Toups, M.D., Distinguished Fellow APA, Functional Medicine Psychiatry, BayAreaWellness.net

Dr. Toups shared this with me and I would suggest you call Great Plains Lab if you are unsure whether you are eligible to order testing:

This includes a free test kit. My understanding about the free test kits at the Organic Acid Testing conference is that they are available for anyone licensed to order testing. You do not have to be a Physician. Their website says the following: “Please note that to receive the FREE Organic Acids Test practitioners must be qualified as MD, DO, NP, NMD, DC, PsyD, PA, LAc or otherwise have the authority to order laboratory testing. Other healthcare practitioners will receive a voucher for 50% off one Organic Acids Test.

The pricing will increase by $40 on 12/22/14, so please register as early as possible to allow time to receive your OAT kit, complete it, mail back and get results before the conference. Things may get a little backed up around the holidays.

For those of you new to Organic Acid Testing, you can also request a complimentary consult at Great Plains once you receive your results. They will go over them with you.

Register here  Early bird expires 12/22/14

Location details are here

Urinary neurotransmitter testing falls short

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lab

I am often asked about urinary neurotransmitter testing and often a new client will come in with results from a test she/he has had done. I would like to share my thoughts on this rather controversial subject and say that I am not a fan and do not ever use this test. Let’s take a deeper dive into this topic.

The question

Here is a question I received right after the Anxiety Summit:

I have had good results using urinary neurotransmitter testing and targeted amino acid therapy and bioidentical hormones. I am able to see if all levels are low, indicating low stomach acid. I am also able to see if histamine or glutamate are high, indicating food hypersensitivities. I also use the levels for balancing and replacing. I know that Julia Ross is opposed to testing. What is your opinion and what did your other speakers [on the Anxiety Summit] say about this topic?

This is my answer:
I am very pleased that this person sees good results using urinary neurotransmitter testing and targeted amino acid therapy.

Why I am not in favor of this testing

However, I am not in favor of this testing for a few reasons:

1) Julia Ross is not in favor of it and having worked with her in her clinic for 2 years I respect her professional opinion and the results she saw when urinary neurotransmitter results didn’t correlate with amino acid questionnaire and trials of amino acids. Julia wrote a great article on this topic for the Townsend Letter and you can access this via the anxiety summit blog for her interview

2) Since leaving the clinic and starting my own practice, I’ve worked with folks who come in with urinary neurotransmitter test results that don’t always with correlate with amino acid questionnaire and trials of the amino acids. But I will be the first to admit that I have not done a thorough analysis of where they haven’t correlated simply because it didn’t seem worth my time.

3) I have heard some rather unpleasant stories from people who have had the urinary neurotransmitter testing done and have been given supplement recommendations based on the results. I just received an email recently from someone who said this:

I was doing xyz’s program last year and the aminos recommended based on urine neurotransmitter testing nearly sent me over the edge with extreme anxiety, insomnia and panic attacks. He had me take 300mg 5-HTP and 3000mg tyrosine a day, based on test results.

We know that anyone can have a bad reaction to supplements. But let me comment on this example: 5-HTP can raise cortisol and be stimulating for some people so it’s not something I recommend for everyone with low serotonin symptoms; 3000mg tyrosine a day is not excessive (1-2 x 500mg , 3 times a day is often typical) BUT will be too much if you don’t need it and can cause anxiety and insomnia.

4) A 2011 paper by Marty Hinz “Validity of urinary monoamine assay sales under the spot baseline urinary neurotransmitter testing marketing model” states that

No peer-reviewed published original research exists which demonstrates that these assays are valid in the treatment of individual patients in the clinical setting.

Low stomach acid and food hypersensitivities?

I’d like to also comment on two other parts of this question:

  • “I am able to see if all levels are low, indicating low stomach acid.” I have not heard this correlation and would use other labs markers for low stomach acid – like total protein, globulin etc – and the person’s response to a HCl trial.
  • “I am also able to see if histamine or glutamate are high, indicating food hypersensitivities.” I have also not heard of this correlation and would use an IgG test and food elimination and challenge to help figure out if someone has food sensitivities.

What do other speakers think?

It was also asked what other speakers on the Anxiety Summit said about this topic:

  • Other than Julia Ross, the only person who mentioned urinary neurotransmitter testing briefly was Dr. Anna Cabeca and we didn’t go deeper into the topic.
  • I did email Dr. Kelly Brogan and she said

I actually don’t use them. Occasionally I do serum amino acid testing (ION panel) but don’t feel that the science is there to support urinary neurotransmitter testing and feel that the reductionism around amino acids and behavioral translation is not consistent with my perspective and not needed for the outcomes I get.

If you listened to our interview on the Anxiety Summit, you’ll remember that Kelly doesn’t feel that low serotonin is a factor in anxiety and depression.

  • I will be following up with some of the other speakers like Josh Friedman, Hyla Cass, Amy Day and Corey Schuler.

What do Dr Weil and Nora Gedgaudas think?

I’d like to share some perspectives from a few others:

I checked with David Perlmutter, M.D., a neurologist colleague in Florida, about the accuracy of urine testing for neurotransmitters. He told me that neurotransmitters and their precursors are produced in abundance throughout the body and to assume that what is collected in the urine reflects what’s going on in the brain is a stretch.

Unfortunately Dr. Weil goes on to discredit salivary cortisol testing which has plenty of research supporting how effective it is!

  • Nora Gedgaudas, author of Primal Body Primal Mind states this on her site:

I have considered the urinary testing approach and was even enamored of the concept at first. Once I looked into the idea more closely, though, it just didn’t add up for me. I have been using amino acids now to address issues of mood, health and cognitive functioning for over 20 years. I have never used anything other than mood/symptomatic screening to guide amino acid supplementation. Results tend to be uniformly good to excellent. The sheer overwhelming complexity of amino acid/neurotransmitter activity in the human body/brain-and the compartmentalized nature of the biochemistry of each seems to best lend itself to a more functional and symptom-related evaluation. Lab testing simply falls short of the mark here.

I could not agree more with Nora’s comments. These are my exact thoughts. Here is the amino acids mood questionnaire I use with my clients. Based on symptoms we do amino acid trials and based on their response (which can happen as quickly as 5 minutes) we know if we’re on the right track.

I’ll be the first to say we don’t always have all the research to support what we do in the nutritional/integrative world and do agree that testing is extremely valuable but in this case I do not recommend urinary neurotransmitter testing as it does fall short in terms of accuracy and consistency.

I’d love to hear your thoughts and experiences. Have you been tested and had good results? Bad results? Are you a health practitioner and say ‘yes’ or ‘no’ to this testing?