Impacts of Fermented Plant-based Products High in Protein on Gut Microbiota and Health

Metabolic Syndrome Clinical Trial

Official title:

Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health: a Randomized, Controlled, Cross-over Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06393114
• Other study ID #: HE 101060247
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of consuming fermented oat-based products on gut and overall human health. It is a randomized, controlled, cross-over trial with a dietary intervention.

A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented oat-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out).

During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.

Description:

Plant-based protein sources, such as those derived from oats, are experiencing high demand due to their role in reducing reliance on animal products and promoting a more sustainable food system. Despite this, there is limited information available regarding the impact of components like fibre in plant-based foods on protein and other nutrients' metabolism.

Food fermentation emerges as a potential solution to enhance the absorption of plant-based protein and various nutrients in the small intestine. This is achieved by reducing antinutrients and facilitating the absorption process. Additionally, food fermentation has implications for the composition and metabolic activity of the gut microbiota, influencing metabolism, immune responses, intestinal function, and overall health. The metabolism of tryptophan in the gut, modulated by the gut microbiota and the production of various metabolites, may serve as a key link in these observed effects.

The fermentation of plant-based foods potentially enhances the beneficial health effects of these foods, and investigating this contributes to an increased understanding of the gut-mediated health effects of foods and the mechanisms behind them. This study will be part of a European research project HealthFerm.

Detailed objectives are to:

1. compare fermented and unfermented plant-based food products to blood lipid and glucose metabolism and gastrointestinal comfort as well as perceived and observed overall well-being.

2. study the effects of fermented and unfermented plant-based food consumption on the markers for gut permeability and inflammation.

3. study the difference in microbiota composition and diversity after consuming fermented and unfermented plant-based foods and its contribution to cardiometabolic outcomes.

4. study the difference in microbiota-related metabolites, especially tryptophan metabolites between fermented and unfermented plant-based foods.

A total of 100 participants will be enrolled in this randomized, controlled, cross-over trial, during which they will eat both fermented and unfermented oat-based products as part of their habitual diet. The study follows this sequence:

Weeks 1-3: Habitual diet Weeks 4-6: Dietary Intervention 1 Weeks 7-9: Habitual diet (wash-out) Weeks 10-12: Dietary Intervention 2

Blood, urinary and faecal samples, as well as food diaries and questionnaires, are collected at the end of each study period to assess participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota. In addition, participants' values and attitudes towards fermented foods are assessed. At the end of the study, participants will receive their laboratory results and dietary guidance for their habitual diet from a registered dietitian.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Waist circumference >90 cm (women) or >100 cm (men) OR BMI 27-35 kg/m2

• One of the following:

• raised blood pressure (= 130/85 mmHg)

• raised fasting plasma glucose (= 5.6 mmol/l) or triglycerides (= 1.7 mmol/l)

• reduced HDL (women < 1.3 mmol/l, men 1.0 mmol/l)

• Use of cereal products and dairy products or their plant-based alternatives as a part of habitual diet

• Willingness to follow intervention diets for the whole study

Exclusion Criteria:

• Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., chronic liver, thyroid, kidney, or gastrointestinal diseases

• Pregnancy and lactation

• Gluten-free or vegan diet

• Recent use of antibiotics (within 3 months)

• Gastrointestinal surgery (within 6 months)

• Alcohol abuse (AUDIT = 15 p and measures of liver function)

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Other:
• Fermented oat-based product
Participants will incorporate a novel fermented product into their habitual diet for three weeks. In addition, the consumption of dairy and plant-based dairy alternatives is restricted. Cereal product consumption, specifically bread and porridge, is slightly restricted to prevent gastrointestinal symptoms caused by the increased intake of dietary fibre. Participants will receive dietary guidance on how to follow the intervention diet, as well as potential supplement recommendations provided by the authorized nutritionist.
• Unfermented oat-based product
Participants will incorporate a novel unfermented product into their habitual diet for three weeks. Dietary adjustments and other guidance are consistent with those described during the fermented product intervention.

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (5)

Lead Sponsor	Collaborator
University of Eastern Finland	ETH Zurich, KU Leuven, Umeå University, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker 1	P-hs-CRP (mg/l)	Weeks 3, 6, 9, and 12
Primary	Inflammatory marker 2	IL-22	Weeks 3, 6, 9, and 12
Primary	Inflammatory marker 3	LBP (µg/ml)	Weeks 3, 6, 9, and 12
Secondary	Changes in the composition gut microbiota	Composition of gut microbiota will be analysed from faecal samples	Weeks 3, 6, and 12
Secondary	Glucose metabolism	fP-Gluk and B-HbA1C (mmol/l)	Weeks 3, 6, 9, and 12
Secondary	Insulin response	fP-Insu (mU/l)	Weeks 3, 6, 9, and 12
Secondary	Lipid metabolism	fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l)	Weeks 3, 6, 9, and 12
Secondary	Tryptophan metabolism	Tryptophan metabolites will be analysed with non-targeted metabolomics.	Weeks 3, 6, 9, and 12
Secondary	Self-reported overall health	Short Form-36 Health Survey (SF-36). Different sections are rated from 0 to 100 points, where higher scores mean better perceived health.	Weeks 3, 6, 9, and 12
Secondary	Self-reported mental health	General Health Questionnaire-12 (GHQ-12). The questionnaire is rated from 0 to 12 points, where higher score means greater psychological distress.	Weeks 3, 6, 9, and 12
Secondary	Self-reported gut health	Gastrointestinal Symptoms Rating Scale (GSRS)	Weeks 3, 6, 9, and 12
Secondary	Attitudes and values	Unvalidated questionnaire	Weeks 0 and 12
Secondary	Opinions about the study products	Unvalidated questionnaire	Weeks 6 and 12