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OpenTrials
Completed

NCT Number: NCT05459662

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1004, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oat based porridge

Dietary Supplement

Consume one preparation per day, orally

plant based preparation

Dietary Supplement

Consume one preparation per day, orally

Primary outcomes

  1. Microbiota diversity & composition

    Time frame: Throughout 14 days of product intake

    Measured by Next Generation Sequencing (NGS)

Secondary outcomes

  1. Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)

    Time frame: 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).

  2. Change in Short Chain Fatty Acids (SCFA) in the stool

    Time frame: Throughout 14 days of product intake

    Measured using Gas Chromatography (GC)

  3. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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