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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: oat based porridge; Dietary supplement: plant based preparation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1004
      • Clinical Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Oat based porridge; 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; Consume one preparation per day, orally
Active Comparator: Enriched plant-based meal; 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; Consume one preparation per day, orally

What is the study measuring?

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
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
Change in Short Chain Fatty Acids (SCFA) in the stool	Measured using Gas Chromatography (GC)	Throughout 14 days of product intake

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2106NRC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No