Impact of Consuming a Plant-based Enriched Meal on the Adult Gut Microbiome

Study Overview
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Brief Summary
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The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.

Official Title
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A Randomized Cross-over Double Arm Control Trial Evaluating the Impact of the Daily Consumption of Plant-based Diversified Meal Over a 2 Weeks Period on the Adult Gut Microbiome

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: oat based porridge
* Dietary Supplement: plant based preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years, Healthy participants, both male and female, BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2, Able to understand and to sign a written informed consent prior to study enrolment. Exclusion Criteria: Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation, Known food allergy and intolerance e.g. lactose intolerance, nuts allergy, Habitually, have < 5 spontaneous bowel movements on average per week, Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day Prior gastrointestinal surgery (apart from appendectomy or herniotomy), Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment, Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment, Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents, Currently participating in another interventional clinical trial or research project, Alcohol intake > 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse, Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment, Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets, Artificially sweetened beverage intake >1000 ml/ per day, Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating, Subject having a hierarchical or family link with the research team members, Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Oat based porridge<br>Oat based porridge prepared with 64g of oat, 200ml of milk and 10 g of honey by the participant and consumed orally daily for 14 days as breakfast replacement | Dietary Supplement: oat based porridge<br>* Consume one preparation per day, orally<br>|
| Active Comparator: Enriched plant-based meal<br>Enriched plant-based meal pots (400 g) mixed with 25g of seeds and nuts consumed orally daily for 14 days as breakfast replacement | Dietary Supplement: plant based preparation<br>* Consume one preparation per day, orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota diversity & composition | Measured by Next Generation Sequencing (NGS) | Throughout 14 days of product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status). | Throughout 14 days of product intake | 
| Change in Short Chain Fatty Acids (SCFA) in the stool | Measured using Gas Chromatography (GC) | Throughout 14 days of product intake | 
| Gastrointestinal Symptom Rating Scale (GSRS) | Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment. | Throughout 14 days of product intake |