Energy Expenditure12OATSNCT06951386
The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
A study testing with short-chain fatty acids enriched drink and unenriched oat drink in people with Energy Expenditure and Metabolic Syndrome, run by KU Leuven at 1 site in Belgium.
Trial summary
During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Energy Expenditure, Metabolic Syndrome, Anthropometry
- What is being tested?
- with short-chain fatty acids enriched drink and unenriched oat drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy, lactation or wish to become pregnant
- Previous or current substance/ alcohol dependence or abuse
- Hyper- or hypothyroidism
- Allergy or intolerance to oat milk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristin Verbeke, Prof. contact
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, 3000
Riet Rosseel, Msc, +3216373428, riet.rosseel@kuleuven.be
Kristin Verbeke, Prof., kristin.verbeke@kuleuven.be
About this study
Official title: 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.
Read the 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).
- Conditions
- Energy Expenditure, Metabolic Syndrome, Anthropometry, Body Composition, Glycemia, Lipaemia
- Being tested
- with short-chain fatty acids enriched drink, unenriched oat drink
- Keywords
- short-chain fatty acids, cardiometabolic health
- Medical subject headings
- Metabolic Syndrome, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with short-chain fatty acids enriched drinkDietary supplement
Oat-based drink enriched with 15 g/L short-chain fatty acids
unenriched oat drinkDietary supplement
Oat-based drink
| Study group | Role | What they receive |
|---|---|---|
| Drink enriched with short-chain fatty acids | Active comparator | Treatment with enriched drink Receives: Dietary Supplement: with short-chain fatty acids enriched drink |
| Control drink | Placebo comparator | Treatment with control drink Receives: Dietary Supplement: unenriched oat drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglycerides
Triglyceride concentrations will be measured in fasting state
Measured: During study visit 1(baseline) and visit 4 (end of intervention, week 12)
Secondary outcomes (40)
Fasting glycemia
In fasting state glucose will be measured
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Fasting energy expenditure
Energy expenditure will be measured for 30 minutes in fasting state using indirect calorimetry
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: body weight
Body weight will be measured at the start of the visit
Measured: Baseline, week 4, week 8 and week 12
Blood pressure
Systolic and diastolic blood pressure will be measured at the start of the visit
Measured: Baseline, week 4, week 8 and week 12
Insulin resistance: HOMA-IR
HOMA-IR will be determined using fasting and postprandial (after 30 min) glucose and insulin levels.
Measured: During study visit 1 (baseline) and 4 (12 weeks)
HbA1c
Glycosylated hemoglobin HbA1c will be measured in fasting state
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Short-chain fatty acids in stool
Short-chain fatty acids in stool will be measured before and after the intervention
Measured: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)
Incretin hormone GLP1
GLP-1 will be measured in fasting and postprandial state (30, 60, 90, 120, 150,180, 240, 300, 360 min)
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Cytokines
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)
Measured: During study visit 1 (baseline) and 4 (12 weeks)
24 hour diet recall
Subjects will complete an online 24 hour diet recall
Measured: Before the intervention and during week 4, 8 and 12 of the intervention
Postprandial glycemia
Glucose concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Postprandial lipaedemia: triglycerides
Triglycerides will be measured after a mixed meal tolerance test (30, 60, 90, 120, 150, 180, 240, 300, 360 min)
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Short-chain fatty acids in blood
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).
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Appetite measurements
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).
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Physical activity measurement
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.
Measured: At the end of study visit 1 (baseline) and 4 (12 weeks)
Postprandial energy expenditure
Energy expenditure will be measured for 3 hours after the mixed meal tolerance test
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)
Fasting blood lipids
Total, HDL-, LDL-cholesterol (mg/dl) will be measured in fasting state
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Metabolomics
Untargeted metabolomics analysis will be performed on fasting blood sample
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Fasting insulinemic response
In fasting state the insulin concentration will be measured
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: waist and hip circumference
Waist- and hip circumference will be measured at the start of the visit
Measured: Baseline, week 4, week 8 and week 12
Gut hormone: PYY
PYY will be measured in postprandial state at 30, 60, 90, 120, 180, 240, 300 and 360 min
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
LBP
LBP will be measured in fasting state
Measured: During study visit 1 (baseline) and 4 (12 weeks)
HOMA-B
HOMA-B will be measured in fasting state
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Insulinogenic index
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))
Measured: During study visit 1 (baseline) and 4 (12 weeks)
Postprandial insulin
Insulin concentrations will be measured 30,60,90,120,150,180,240,300 and 360 min after a mixed meal tolerance test
Measured: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Postprandial lipaedemia: total, LDL and HDL cholesterol
Total, HDL and LDL cholesterol will be measured after 30,60,90,120,150,180,240,300 and 360 min (mg/dl)
Measured: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
Postprandial lipaedemia: free fatty acids
Free fatty acids will be measured at 30,60,90,120,150,180,240,300 and 360 min (µmol/l)
Measured: During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours)
% fat mass
% fat mass is measured using a bodystat bioelectrical impedance device, expressed in %
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
kg fat mass
kg fat mass is measured using a bodystat bioelectrical impedance device, expressed in kg
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
fat free mass (kg)
Fat free mass is measured using a bodystat bioelectrical impedance device, expressed in kg
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Dry lean weight (kg)
Dry lean weight is measured using a bodystat bioelectrical impedance device, expressed in kg
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Water percentage
% water in body is measured using a bodystat bioelectrical impedance device, expressed in %
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Total body water (L)
Volume of body water is measured using a bodystat bioelectrical impedance device, expressed in liters
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Average energy requirements
Average energy requirements is measured using a bodystat bioelectrical impedance device, expressed in kcal/day
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Basal metabolic rate
Basal metabolic rate (BMR) is measured using a bodystat bioelectrical impedance device, expressed in kcal/day
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
basal metabolic rate (BMR)/ body weight
BMR/body weight is measured using a bodystat bioelectrical impedance device, expressed in kcal/kg
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
BMI
BMI is measured using a bodystat bioelectrical impedance device, expressed in kg/m²
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Waist to hip ratio
Waist to hip ratio is measured using a bodystat bioelectrical impedance device
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Resistance during bioelectrical impedance
Resistance is measured using a bodystat bioelectrical impedance device, expressed in Ohm
Measured: During all 4 study visits (0, 4,8 and 12 weeks) (fasted state)
Free fatty acids in fasting state
Free fatty acids will be measured in fasted state (µmol/l)
Measured: During study visit 1 (baseline) and 4 (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start11 Feb 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951386
- Sponsor's protocol ID
- S69712
- Acronym
- 12OATS
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06951386
- Acronym / sponsor ID
- 12OATS / S69712
- Conditions
- Energy Expenditure, Metabolic Syndrome, Anthropometry, Body Composition, Glycemia, Lipaemia
- Keywords
- short-chain fatty acids, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drink enriched with short-chain fatty acids | Active comparator | Dietary Supplement: with short-chain fatty acids enriched drinkTreatment with enriched drink |
| Control drink | Placebo comparator | Dietary Supplement: unenriched oat drinkTreatment with control drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- knowledge of English
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with short-chain fatty acids enriched drinkOat-based drink enriched with 15 g/L short-chain fatty acids | Dietary supplement | Drink enriched with short-chain fatty acids |
| unenriched oat drinkOat-based drink | Dietary supplement | Control drink |
Primary outcome
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
40 secondary outcomes
Fasting glycemia
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Fasting energy expenditure
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: body weight
Time frame: Baseline, week 4, week 8 and week 12
Blood pressure
Time frame: Baseline, week 4, week 8 and week 12
Insulin resistance: HOMA-IR
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
HbA1c
Time frame: 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)
Incretin hormone GLP1
Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)
Cytokines
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
24 hour diet recall
Time frame: 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)
Postprandial lipaedemia: triglycerides
Time frame: 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)
Appetite measurements
Time frame: 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)
Postprandial energy expenditure
Time frame: During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours)
Fasting blood lipids
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Metabolomics
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Fasting insulinemic response
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Anthropometrics: waist and hip circumference
Time frame: 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)
LBP
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
HOMA-B
Time frame: During study visit 1 (baseline) and 4 (12 weeks)
Insulinogenic index
Time frame: 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)
Postprandial lipaedemia: total, LDL and HDL cholesterol
Time frame: 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)
% fat mass
Time frame: 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)
fat free mass (kg)
Time frame: 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)
Water percentage
Time frame: 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)
Average energy requirements
Time frame: 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)/ body weight
Time frame: 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)
Waist to hip ratio
Time frame: 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)
Free fatty acids in fasting state
Time frame: During study visit 1 (baseline) and 4 (after 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No. No IPD data will be shared with other researchers.
Related trials for Energy Expenditure
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Recruiting
Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Healthy Adult
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Verbeke, Prof. contact
Kristin Verbeke, Prof. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with short-chain fatty acids enriched drink and unenriched oat drink in people with Energy Expenditure and Metabolic Syndrome, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riet Rosseel, Msc (+3216373428, riet.rosseel@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting triglycerides (time frame: During study visit 1(baseline) and visit 4 (end of intervention, week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.