The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome (12OATS)

April 30, 2025 updated by: Kristin Verbeke, KU Leuven

The Impact of 12 Weeks Intervention With Plant-based Oat Drink Rich in Short-chain Fatty Acids on Postprandial Lipidemia in Individuals at Risk for Metabolic Syndrome

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Drink enriched with short-chain fatty acids
Treatment with enriched drink
Dietary supplement: with short-chain fatty acids enriched drink
Oat-based drink enriched with 15 g/L short-chain fatty acids
Placebo Comparator: Control drink
Treatment with control drink
Dietary supplement: unenriched oat drink
Oat-based drink

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting triglycerides
Time Frame: During study visit 1(baseline) and visit 4 (end of intervention, week 12)
Triglyceride concentrations will be measured in fasting state
During study visit 1(baseline) and visit 4 (end of intervention, week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting glycemia
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
In fasting state glucose will be measured
During study visit 1 (baseline) and 4 (12 weeks)
Fasting energy expenditure
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
Energy expenditure will be measured for 30 minutes in fasting state using indirect calorimetry
During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: body weight
Time Frame: Baseline, week 4, week 8 and week 12
Body weight will be measured at the start of the visit
Baseline, week 4, week 8 and week 12
Blood pressure
Time Frame: Baseline, week 4, week 8 and week 12
Systolic and diastolic blood pressure will be measured at the start of the visit
Baseline, week 4, week 8 and week 12
Insulin resistance: HOMA-IR
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
HOMA-IR will be determined using fasting and postprandial (after 30 min) glucose and insulin levels.
During study visit 1 (baseline) and 4 (12 weeks)
HbA1c
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
Glycosylated hemoglobin HbA1c will be measured in fasting state
During study visit 1 (baseline) and 4 (12 weeks)
Short-chain fatty acids in stool
Time Frame: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)
Short-chain fatty acids in stool will be measured before and after the intervention
Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)
Incretin hormone GLP1
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
GLP-1 will be measured in fasting and postprandial state (30, 60, 90, 120, 150,180, 240, 300, 360 min)
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
24 hour diet recall
Time Frame: Before the intervention and during week 4, 8 and 12 of the intervention
Subjects will complete an online 24 hour diet recall
Before the intervention and during week 4, 8 and 12 of the intervention
Postprandial glycemia
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Glucose concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Postprandial lipaedemia: triglycerides
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Triglycerides will be measured after a mixed meal tolerance test (30, 60, 90, 120, 150, 180, 240, 300, 360 min)
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Short-chain fatty acids in blood
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Short-chain fatty acids (acetate, propionate and butyrate) concentrations will be measured in fasting and postprandial state (30, 60, 90, 120, 180, 240, 300, 360 min).
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Appetite measurements
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Appetite in response to mixed meal tolerance test, will be measured using 100 millimeter (mm) Visual Analogue Scale (indicating score on line of 100 mm, 0 mm: don't agree, 100 mm: totally agree) in fasting (i.e. 0 minute) and postprandial state (30, 60, 90, 120,150, 180, 240, 300 and 360 min).
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Physical activity measurement
Time Frame: At the end of study visit 1 (baseline) and 4 (12 weeks)
Individuals complete the short form of the international physical activity questionnaire (IPAQ) before and after the intervention. In the IPAQ participants fill in the number of days/ week they spent doing vigorous, moderate activity and walking and how long (hours and minutes) per day they do this. It also includes a question about how long they sit on a day.
At the end of study visit 1 (baseline) and 4 (12 weeks)
Postprandial energy expenditure
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)
Energy expenditure will be measured for 3 hours after the mixed meal tolerance test
During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)
Metabolomics
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
Untargeted metabolomics analysis will be performed on fasting blood sample
During study visit 1 (baseline) and 4 (12 weeks)
Fasting insulinemic response
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
In fasting state the insulin concentration will be measured
During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: waist and hip circumference
Time Frame: Baseline, week 4, week 8 and week 12
Waist- and hip circumference will be measured at the start of the visit
Baseline, week 4, week 8 and week 12
Gut hormone: PYY
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
PYY will be measured in postprandial state at 30, 60, 90, 120, 180, 240, 300 and 360 min
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
LBP
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
LBP will be measured in fasting state
During study visit 1 (baseline) and 4 (12 weeks)
HOMA-B
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
HOMA-B will be measured in fasting state
During study visit 1 (baseline) and 4 (12 weeks)
Insulinogenic index
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
IGI will be measured in fasting state. IGI is ratio of (postprandial insulin (30 min) -fasting insulin (mU/L)) over (postprandial glucose (30 min) - fasting glucose (mmol/L))
During study visit 1 (baseline) and 4 (12 weeks)
Postprandial insulin
Time Frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Insulin concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test
During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
% fat mass
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
% fat mass is measured using a bodystat bioelectrical impedance device, expressed in %
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
kg fat mass
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
kg fat mass is measured using a bodystat bioelectrical impedance device, expressed in kg
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
fat free mass (kg)
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Fat free mass is measured using a bodystat bioelectrical impedance device, expressed in kg
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Dry lean weight (kg)
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Dry lean weight is measured using a bodystat bioelectrical impedance device, expressed in kg
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Water percentage
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
% water in body is measured using a bodystat bioelectrical impedance device, expressed in %
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Total body water (L)
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Volume of body water is measured using a bodystat bioelectrical impedance device, expressed in liters
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Average energy requirements
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Average energy requirements is measured using a bodystat bioelectrical impedance device, expressed in kcal/day
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Basal metabolic rate
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Basal metabolic rate (BMR) is measured using a bodystat bioelectrical impedance device, expressed in kcal/day
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
basal metabolic rate (BMR)/ body weight
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
BMR/body weight is measured using a bodystat bioelectrical impedance device, expressed in kcal/kg
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
BMI
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
BMI is measured using a bodystat bioelectrical impedance device, expressed in kg/m²
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Waist to hip ratio
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Waist to hip ratio is measured using a bodystat bioelectrical impedance device
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Resistance during bioelectrical impedance
Time Frame: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Resistance is measured using a bodystat bioelectrical impedance device, expressed in Ohm
During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Cytokines
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
Cytokines such as IL-1β, IL-6, IL-10, TNF-alpha, IL-13 and interferon (IFN)-γ will be measured in fasting state (unit: pg/ml)
During study visit 1 (baseline) and 4 (12 weeks)
Fasting blood lipids
Time Frame: During study visit 1 (baseline) and 4 (12 weeks)
Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state
During study visit 1 (baseline) and 4 (12 weeks)
Postprandial lipaedemia: total, LDL and HDL cholesterol
Time Frame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
Total, HDL and LDL cholesterol will be measured after 30,60,90,120,150,180,240,300 and 360 min (mg/dl)
During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
Postprandial lipaedemia: free fatty acids
Time Frame: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
Free fatty acids will be measured at 30,60,90,120,150,180,240,300 and 360 min (µmol/l)
During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
Free fatty acids in fasting state
Time Frame: During study visit 1 (baseline) and 4 (after 12 weeks)
Free fatty acids will be measured in fasted state (µmol/l)
During study visit 1 (baseline) and 4 (after 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Verbeke, Prof., KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S69712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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