Healthy
Conditions
Brief summary
The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.
Interventions
DIETARY_SUPPLEMENToat based porridge
Consume one preparation per day, orally
DIETARY_SUPPLEMENTplant based preparation
Consume one preparation per day, orally
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota diversity & composition | Throughout 14 days of product intake | Measured by Next Generation Sequencing (NGS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey) | Throughout 14 days of product intake | 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). |
| Change in Short Chain Fatty Acids (SCFA) in the stool | Throughout 14 days of product intake | Measured using Gas Chromatography (GC) |
| Gastrointestinal Symptom Rating Scale (GSRS) | Throughout 14 days of product intake | 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. |
Countries
Switzerland
Outcome results
None listed