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

NCT05459662 | Completed

• 1 other identifier: 2106NRC2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Microbiota diversity & composition

  Measured by Next Generation Sequencing (NGS)

  Throughout 14 days of product intake

Secondary Outcomes (3)

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

  Throughout 14 days of product intake

• Change in Short Chain Fatty Acids (SCFA) in the stool

  Throughout 14 days of product intake

• Gastrointestinal Symptom Rating Scale (GSRS)

  Throughout 14 days of product intake

Study Arms (2)

Oat based porridge

PLACEBO COMPARATOR

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

Enriched plant-based meal

ACTIVE COMPARATOR

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

Interventions

oat based porridge DIETARY_SUPPLEMENT

Consume one preparation per day, orally

Oat based porridge

plant based preparation DIETARY_SUPPLEMENT

Consume one preparation per day, orally

Enriched plant-based meal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: July 15, 2022
• Study Start: May 5, 2022
• Primary Completion: July 31, 2022
• Study Completion: November 15, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)