The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2026-02-28

Brief Summary

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During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.

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Detailed Description

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The goal of this study is to investigate the impact of consuming every day a drink enriched with short-chain fatty acids for 12 weeks on the cardiometabolic health in individuals at risk of metabolic syndrome. This means the investigators are looking for people with overweight and disrupted cholesterol, high blood pressure or elevated blood glucose. The individuals will consume for 12 weeks a drink either enriched with SCFA or a control drink (randomly allocated). Before and after this period (study visit 1 and 4), a study visit will take place in which metabolic parameters will be measured such as blood pressure, body weight, waist- and hip circumference, body composition, energy expenditure, glucose, insulin and blood lipids. After 4 and 8 weeks, anthropometrics, blood pressure and body composition will be measured during a short study visit (study visit 2 and 3).

Conditions

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Energy Expenditure Metabolic Syndrome Anthropometry Body Composition Glycemia Lipaemia Metabolomics Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Drink enriched with short-chain fatty acids

Treatment with enriched drink

Group Type ACTIVE_COMPARATOR

with short-chain fatty acids enriched drink

Intervention Type DIETARY_SUPPLEMENT

Oat-based drink enriched with 15 g/L short-chain fatty acids

Control drink

Treatment with control drink

Group Type PLACEBO_COMPARATOR

unenriched oat drink

Intervention Type DIETARY_SUPPLEMENT

Oat-based drink

Interventions

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with short-chain fatty acids enriched drink

Oat-based drink enriched with 15 g/L short-chain fatty acids

Intervention Type DIETARY_SUPPLEMENT

unenriched oat drink

Oat-based drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* male and female participants
* central obesity ( BMI ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men)
* One additional risk factor for metabolic syndrome:

1. Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)
2. Triglyceride concentration ≥ 150 mg/dl
3. HDL-cholesterol \< 40 mg/dl for women/ \< 50 mg/dl for men
4. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
* knowledge of English

Exclusion Criteria

* gastrointestinal disorders such as IBD, IBS, celiac disease, chronic constipation, chronic diarrhoea
* history of abdominal surgery, except for appendectomy
* Use of antihypertensive, cholesterol lowering, glucose-regulating drugs and corticosteroids
* Use of antibiotics 3 months prior to the start or during the study
* Use of probiotics and prebiotics 2 weeks prior to the start of the study/ during the study
* Being on weight loss, gluten-free, lactose-free or vegan diet
* Pregnancy, lactation or wish to become pregnant
* Previous or current substance/ alcohol dependence or abuse
* Hyper- or hypothyroidism
* Allergy or intolerance to oat milk

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No