A practice based trial of a combination of nutritional interventions: probiotics, glutamine and fish oils in patients experiencing psychological distress.
Investigating the effect of a novel nutritional intervention (probiotics, glutamine and fish-oil) on mild-moderate psychological distress in adults: a concurrent multiple baseline design
Southern Cross University
10 participants
Jul 15, 2019
Interventional
Conditions
Summary
Mental health problems affect one in five Australians every year. Psychological distress may be a risk factor for more serious mental health conditions. Recent research on the microbiome of the gastrointestinal tract suggests a complex interaction between this community of bacteria and the health and mental well-being of the host. Lack of balance in the microbiome is often indicated by mild digestive discomfort. This study investigates a combination of nutrients that have been found to benefit the gastrointestinal tract (glutamine), the microbiome (probiotics) and support healthy mood balance (fish oil) in 10 individuals who suffer mild digestive symptoms and psychological distress. This study aims to investigate the effects of this combination of nutrients on perceptions of psychological distress in these 10 specific individuals. The data from the placebo phase and the ‘active treatment’ phase will be compared for each individual participant and will also be combined to explore some preliminary more general findings that will help with the design of future studies in this area.
Eligibility
Inclusion Criteria5
- Individuals with:
- a score of greater than or equal to 16 and less than 30 on the K-10 scale
- symptoms of mild gut dysfunction (e.g. abdominal cramps or sharp pains, recurrent diarrhoea or constipation, excessive wind, abdominal bloating)
- agree to comply with the study protocols
- willing to have blood taken on two occasions during the study
Exclusion Criteria9
- Individuals
- taking immunosuppressive medication
- taking Warfarin or other anticoagulant medication
- who have major surgery within the last 6 months
- diagnosed with chronic mental health conditions and taking prescribed medication for same (unless their condition has been stable for a minimum of 12 months)
- with diabetes
- with BMI greater than or equal to 35
- unexplained weight loss
- Females who are lactating, pregnant or planning to become pregnant
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Interventions
The intervention consisted of 3 nutritionally based supplements or their matched placebos. In this multiple baseline study design participants were randomised into 3 groups based on the duration of their exposure to the verum intervention. Group 1 took 6 weeks of placebos followed by 12 weeks of verum supplements, Group 2 had 8 weeks of placebos followed by 10 weeks of verum supplements and group 3 took placebo for 12 weeks and then 6 weeks of verum supplements. Each participant took two doses of each supplement/placebo supplement each day of the trial. The doseage form and contents of the verum supplements are detailed below per dose. a) Metagenics Ultra Flora Intensive Care (ARTG 286746) 600mg maroon (00 size Vcap with cream coloured powder) clear capsule for oral consumption containing Lactobacillus rhamnosus (LGG®) (10 x 109CFU), Saccharomyces cerevisiae (boulardii) (7.5 x 109 CFU) and Bifidobacterium animalis ssp lactis (BB-12®) (5 x 109 CFU). Participants swallowed one capsule of this probiotic supplement morning and evening. b) Metagenics Glutagenics (ARTG 213315) Powder for oral consumption after dissolving in water. Each 4.33g dose contains: Aloe vera 3.25mg/g (equiv. fresh herb 649.35mg/g); Boswellia serrata 19.48mg/g (equiv. fresh herb 194.8mg/g); Cholecalciferol 1.6233mcg/g; Glutamine 285.71mg/g; Larix arabinogalactan 259.74mg/g; Retinol palmitate 178.57mcg/g; Zinc amino acid chelate 9.74mg/g. Participants took one dose: 7.7g (two scoops - scooop included) of this oral powder supplement in 200ml water morning and evening. All practitioner researchers were qualified naturopathic practitioners, apart from one who was a qualified nutritionist. It was beyond the scope of this practitioner reseracher to prescribe herbal medicines so the two participants that she monitored were given the same total daily dose of glutamine (571 mg) as used in the above supplement, encapsulated into 3 opaque capsules which were taken twice a day, by these two participants or a matched placebo. c) Metagenics Metapure EPA/DHA oral liquid (ARTG 227557). Each ml contains: concentrated fish Omega-3 triglycerides 952.38 mg/mL. Participants took 2.1ml twice daily with meals (breakfast and dinner). Supplements were returned at each study clinic and the quantity remaining was rmeasured and recorded by the practitioner reserachers as a) the number of capsules, b) the weight of the powder and c) the volume of the liquid.
Locations(1)
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ACTRN12620000928910