ObesityNCT02271776
GOS and Insulin Sensitivity
A study testing Galactooligosaccharide and maltodextrin in people with Obesity and Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: To investigate the effects of a 12-week supplementation of GOS on… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Galactooligosaccharide and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Oct 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.
- In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
Who cannot join
- diabetes mellitus
- gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- lactose intolerance and other digestive disorders
- cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- disease with a life expectancy shorter than 5 years
- abuse of products (alcohol consumption > 15 units/week, or any drugs)
- excessive nicotine use defined as >20 cigarettes per day
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
About this study
Official title: The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis
Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Galactooligosaccharide, maltodextrin
- Keywords
- Insulin Sensitivity
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalactooligosaccharideDietary supplement
The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
maltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Galactooligosaccharide | Active comparator | 5g 3x per day for 12 weeks Receives: Dietary Supplement: Galactooligosaccharide |
| maltodextrin | Placebo comparator | 3x per day for 12 weeks (isocaloric to intervention) Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic insulin sensitivity
Measured: change from baseline at 12 week supplementation
Secondary outcomes (5)
substrate oxidation and energy expenditure
Measured: change from baseline at 12 week supplementation
plasma markers of substrate and energy metabolism
Measured: change from baseline at week 1 and at 12 week supplementation
fecal and plasma SCFA concentrations
Measured: change from baseline at week 1 and at 12 week supplementation
fecal microbiota composition
Measured: change from baseline at week 1 and at 12 week supplementation
skeletal muscle and adipose tissue gen and protein expression
Measured: change from baseline at week 1 and at 12 week supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271776
- Sponsor's protocol ID
- METC 143026
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canfora EE, van der Beek CM, Hermes GDA, Goossens GH, Jocken JWE, Holst JJ, van Eijk HM, Venema K, Smidt H, Zoetendal EG, Dejong CHC, Lenaerts K, Blaak EE. Supplementation of Diet With Galacto-oligosaccharides Increases Bifidobacteria, but Not Insulin Sensitivity, in Obese Prediabetic Individuals. Gastroenterology. 2017 Jul;153(1):87-97.e3. doi: 10.1053/j.gastro.2017.03.051. Epub 2017 Apr 8.
PubMed 28396144
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT02271776
- Acronym / sponsor ID
- METC 143026
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- 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 our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galactooligosaccharide | Active comparator | Dietary Supplement: Galactooligosaccharide5g 3x per day for 12 weeks |
| maltodextrin | Placebo comparator | Dietary Supplement: maltodextrin3x per day for 12 weeks (isocaloric to intervention) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.
- In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
Key exclusion criteria (7 listed)
- diabetes mellitus
- gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- lactose intolerance and other digestive disorders
- cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- disease with a life expectancy shorter than 5 years
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 |
|---|---|---|
| GalactooligosaccharideThe dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks | Dietary supplement | Galactooligosaccharide |
| maltodextrin | Dietary supplement | maltodextrin |
Primary outcome
systemic insulin sensitivity
Time frame: change from baseline at 12 week supplementation
5 secondary outcomes
substrate oxidation and energy expenditure
Time frame: change from baseline at 12 week supplementation
plasma markers of substrate and energy metabolism
Time frame: change from baseline at week 1 and at 12 week supplementation
fecal and plasma SCFA concentrations
Time frame: change from baseline at week 1 and at 12 week supplementation
fecal microbiota composition
Time frame: change from baseline at week 1 and at 12 week supplementation
skeletal muscle and adipose tissue gen and protein expression
Time frame: change from baseline at week 1 and at 12 week supplementation
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 10 Apr 2018.
- Derived from this study: PubMed 28396144Canfora EE, van der Beek CM, Hermes GDA, Goossens GH, Jocken JWE, Holst JJ, van Eijk HM, Venema K, Smidt H, Zoetendal EG, Dejong CHC, Lenaerts K, Blaak EE. Supplementation of Diet With Galacto-oligosaccharides Increases Bifidobacteria, but Not Insulin Sensitivity, in Obese Prediabetic Individuals. Gastroenterology. 2017 Jul;153(1):87-97.e3. doi: 10.1053/j.gastro.2017.03.051. Epub 2017 Apr 8.
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), 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.
Ellen E Blaak principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galactooligosaccharide and maltodextrin in people with Obesity and Type 2 Diabetes Mellitus, 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 2 inclusion and 7 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 10 Apr 2018. 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?
systemic insulin sensitivity (time frame: change from baseline at 12 week supplementation). 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 NCT02271776, 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 10 Apr 2018.