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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05459662
• Other study ID #: 2106NRC2
• Status: Completed
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 15, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• oat based porridge
Consume one preparation per day, orally
• plant based preparation
Consume one preparation per day, orally

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota diversity & composition	Measured by Next Generation Sequencing (NGS)	Throughout 14 days of product intake
Secondary	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
Secondary	Change in Short Chain Fatty Acids (SCFA) in the stool	Measured using Gas Chromatography (GC)	Throughout 14 days of product intake
Secondary	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