ObesityNCT04714944
Fiber and Insulin Sensitivity
A study testing Whole fiber product in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Whole fiber product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2021to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 kg/m2)
Who cannot join
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
- Plans to lose weight or following of a hypocaloric diet;
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
Show all 14Show fewer
- Intensive exercise training more than three hours a week;
- Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
- Regular use of laxation products;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Follow a vegetarian diet.
- Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
- The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbial Substrate Switch to Improve Metabolic Health
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.
The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Placebo, Whole fiber product
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Supplementation period 12 weeks
Whole fiber productDietary supplement
Supplementation period 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | isocaloric placebo Receives: Dietary Supplement: Placebo |
| whole fiber product | Experimental | 15 g for 2 weeks, followed by 30 g for 10 weeks Receives: Dietary Supplement: Whole fiber product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral insulin sensitivity
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Measured: Before and 12 week after the start of the intervention
Secondary outcomes (12)
hepatic and adipose tissue insulin sensitivity
The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Measured: Before and 12 week after the start of the intervention
Energy expenditure (indirect calorimetry)
The change in energy expenditure as measured via ventilated hood system
Measured: Before and 12 week after the start of the intervention
Substrate oxidation (indirect calorimetry)
The change in substrate oxidation as measured via ventilated hood system
Measured: Before and 12 week after the start of the intervention
Faecal and circulating SCFA
The change in faecal and circulating SCFA
Measured: Before and 12 week after the start of the intervention
Faecal microbiota composition and in vitro microbial activity testing
The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing
Measured: Before and 12 week after the start of the intervention
In vitro microbial activity testing
The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon
Measured: Before and 12 week after the start of the intervention
Circulating hormones such as insulin
The change in circulating hormones in peripheral blood
Measured: Before and 12 week after the start of the intervention
Circulating metabolites such as glucose
The change in metabolites in peripheral blood
Measured: Before and 12 week after the start of the intervention
Circulating inflammatory markers such as TNF
The change in inflammatory markers in peripheral blood
Measured: Before and 12 week after the start of the intervention
body weight
The change in body weight in kg
Measured: Before and 12 week after the start of the intervention
body composition
The change in body compostion as assessed using DEXA scans
Measured: Before and 12 week after the start of the intervention
liver fat content
The change in liver fat content as assessed by proton magnetic resonance spectrometry
Measured: Before and 12 week after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start5 Feb 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714944
- Sponsor's protocol ID
- NL72483.068.20
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2020
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Omary L, Canfora EE, Puhlmann ML, Gavriilidou A, Rijnaarts I, Holst JJ, Op den Kamp-Bruls YMH, de Vos WM, Blaak EE. Intrinsic chicory root fibers modulate colonic microbial butyrate-producing pathways and improve insulin sensitivity in individuals with obesity. Cell Rep Med. 2025 Jul 15;6(7):102237. doi: 10.1016/j.xcrm.2025.102237.
PubMed 40669445
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Substrate Switch to Improve Metabolic Health
- ClinicalTrials.gov ID
- NCT04714944
- Acronym / sponsor ID
- NL72483.068.20
- Conditions
- Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 20 Jan 2021 (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.
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.
The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboisocaloric placebo |
| whole fiber product | Experimental | Dietary Supplement: Whole fiber product15 g for 2 weeks, followed by 30 g for 10 weeks |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 kg/m2)
Key exclusion criteria (14 listed)
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
- Plans to lose weight or following of a hypocaloric diet;
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 |
|---|---|---|
| PlaceboSupplementation period 12 weeks | Dietary supplement | Placebo |
| Whole fiber productSupplementation period 12 weeks | Dietary supplement | whole fiber product |
Primary outcome
Peripheral insulin sensitivity
Time frame: Before and 12 week after the start of the intervention
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
12 secondary outcomes
hepatic and adipose tissue insulin sensitivity
Time frame: Before and 12 week after the start of the intervention
Energy expenditure (indirect calorimetry)
Time frame: Before and 12 week after the start of the intervention
Substrate oxidation (indirect calorimetry)
Time frame: Before and 12 week after the start of the intervention
Faecal and circulating SCFA
Time frame: Before and 12 week after the start of the intervention
Faecal microbiota composition and in vitro microbial activity testing
Time frame: Before and 12 week after the start of the intervention
In vitro microbial activity testing
Time frame: Before and 12 week after the start of the intervention
Circulating hormones such as insulin
Time frame: Before and 12 week after the start of the intervention
Circulating metabolites such as glucose
Time frame: Before and 12 week after the start of the intervention
Circulating inflammatory markers such as TNF
Time frame: Before and 12 week after the start of the intervention
body weight
Time frame: Before and 12 week after the start of the intervention
body composition
Time frame: Before and 12 week after the start of the intervention
liver fat content
Time frame: Before and 12 week after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 40669445Omary L, Canfora EE, Puhlmann ML, Gavriilidou A, Rijnaarts I, Holst JJ, Op den Kamp-Bruls YMH, de Vos WM, Blaak EE. Intrinsic chicory root fibers modulate colonic microbial butyrate-producing pathways and improve insulin sensitivity in individuals with obesity. Cell Rep Med. 2025 Jul 15;6(7):102237. doi: 10.1016/j.xcrm.2025.102237.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole fiber product in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 14 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: finished, as of the sponsor's last update on 12 Feb 2024. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral insulin sensitivity (time frame: Before and 12 week after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714944, which also lists 1 linked publication.
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 12 Feb 2024.