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

NCT06951386 | Recruiting DMC

• 1 other identifier: S69712
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

short-chain fatty acids; cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• Fasting triglycerides

  Triglyceride concentrations will be measured in fasting state

  During study visit 1(baseline) and visit 4 (end of intervention, week 12)

Secondary Outcomes (40)

• Fasting glycemia

  During study visit 1 (baseline) and 4 (12 weeks)

• Fasting energy expenditure

  During study visit 1 (baseline) and 4 (12 weeks)

• Anthropometrics: body weight

  Baseline, week 4, week 8 and week 12

• Blood pressure

  Baseline, week 4, week 8 and week 12

• Insulin resistance: HOMA-IR

  During study visit 1 (baseline) and 4 (12 weeks)

Study Arms (2)

Drink enriched with short-chain fatty acids

ACTIVE COMPARATOR

Treatment with enriched drink

Dietary Supplement: with short-chain fatty acids enriched drink

Control drink

PLACEBO COMPARATOR

Treatment with control drink

Dietary Supplement: unenriched oat drink

Interventions

with short-chain fatty acids enriched drink DIETARY_SUPPLEMENT

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

Drink enriched with short-chain fatty acids

unenriched oat drink DIETARY_SUPPLEMENT

Oat-based drink

Control drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Hyperlipidemias

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Kristin Verbeke, Prof.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riet Rosseel, Msc

CONTACT

+3216373428; riet.rosseel@kuleuven.be

Kristin Verbeke, Prof.

CONTACT

kristin.verbeke@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: April 30, 2025
• Study Start: February 11, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)