ObesityMNGIINCT03135041
The Effect of Prebiotic Fibres on Weight Loss in an Overweight and Obese Population
A study testing Fiber-containing dietary supplement in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres induces greater changes in body weight compared to placebo during 12 weeks of energy restriction in an obese/overweight population. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fiber-containing dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- 26 May 2017to 24 May 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 28-45 kg/m2
- Non-smoking
- Haemoglobin level ≥7 mmol/L
Who cannot join
- Use of antibiotics three months prior to study and during the study. If a participant uses antibiotics prior to randomization, the participant will be invited to be re-screened 3 months after the last use of antibiotics, provided that it is realistic to complete the study no later than the scheduled LPLV
- Weight change >3 kg two months prior to study
- Blood donation other than for this study <1 month prior to study and during study.
- Participation in clinical trials other than for this <1 month prior to study and during study
- Intensive physical training/ elite athlete (>10 hours of strenuous physical activity per week)
- Unstable medication for dyslipidaemia and elevated blood pressure (the participant must have had a stable dose in the three months prior to study start), and use of systemic glucocorticoids
Show all 19Show fewer
- Medication for T2D
- Treatment with metformin
- Dietary supplements with pro- and/or prebiotics and/or fibre 6 weeks prior to study
- Special dietary regimen (vegetarians, vegans etc.), as evaluated by study staff
- Lactose intolerance or allergy to components in the intervention products
- Gluten intolerance
- Maltodextrin intolerance
- Lactation, pregnancy or planning of pregnancy during the study
- Gastro intestinal and liver disorders
- Chronic inflammation disorders (excluding obesity)
- Diagnosed psychiatric disorder including depression requiring treatment
- Surgical treatment of obesity and abdominal surgery
- Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Frederiksberg, Frederiksberg C, 1958
About this study
Official title: Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population
The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres induces greater changes in body weight compared to placebo during 12 weeks of energy restriction in an obese/overweight population.
The hypothesis is that the fiber-containing dietary supplement will:
- Induce greater changes in body weight compared to the placebo group 2) change the gut microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of triglycerides, total and LDL cholesterol
The hypothesis is that the effect of the intervention on weight loss will be partly mediated by the diet-induced changes in the gut microbiota composition.
Read the detailed description
Prebiotics are nutrients that specifically utilized by the gut microbiota. Beneficial health effects of prebiotics are generally attributed to 1) stimulation of beneficial bacteria and SCFA production, and consequently; improved barrier function, regulation of enteroendocrine peptide secretion and resistance to inflammatory stimuli; 2) modulation of lipid metabolism, possibly by suppression of lipogenic enzymes and thus decreased synthesis of lipoproteins and triglycerides; and 3) increased mineral absorption.
Inulin is recognized as a common prebiotic. Fibersol-2 is a resistant starch that has been suggested to induce satiety, when given in a dose of 10 g. Intake of inulin has been shown to induce changes in the microbial abundance and increase production of SCFA19; whereas resistant starch has been shown to improve insulin sensitivity and postprandial glucose AUC20. However, the effects of an intervention with a combination of these two fibers on obesity and body composition during an energy restricted diet have not been addressed. Supplements with other types of fibres in addition to energy restriction have shown additional effects in weight reduction.
In this study, the effects of a combination product of two prebiotic fibres on additional weight loss during energy restriction in a placebo-controlled, randomized parallel study with a duration of 12 weeks will be tested. Furthermore, the effects of the fibres on the gut microbial composition, markers of metabolic syndrome (MetS) and glucose metabolism will be tested. The active diet will contain intervention products high in dietary fibre and the placebo diet will contain maltodextrin. The fiber-containing dietary supplements will add approximately 20 g of prebiotic fibres per day, where approximately 10 g will be inulin and approximately 10 g will be resistant maltodextrin. The intervention products and placebo will be consumed as milk. The fiber-containing dietary supplement is expected to induce additional weight loss, compared to placebo and to affect the gut microbiome and markers of metabolic disease.
- Conditions
- Obesity
- Being tested
- Fiber-containing dietary supplement, Placebo
- Keywords
- Prebiotics, Microbiome, Glucose metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-containing dietary supplementDietary supplement
Effects of fiber-containing dietary supplement on weight loss during energy restriction
PlaceboDietary supplement
Effects of placebo supplement on weight loss during energy restriction
| Study group | Role | What they receive |
|---|---|---|
| Fiber-containing dietary supplement | Experimental | 2 x 200 ml of fiber-enriched UHT milk during 12 weeks of energy restriction Receives: Dietary Supplement: Fiber-containing dietary supplement |
| Placebo | Placebo comparator | 2 x 200 ml of UHT milk with maltodextrin during 12 weeks of energy restriction Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Secondary outcomes (9)
Body composition
Changes in body composition
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Gut microbiota composition and function
Changes in gut microbiota composition and function (faecal samples) assesed by metagenomics
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Glucose metabolism
Glucose and insulin homeostasis
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Lipid metabolism
Analyses of lipids in blood samples
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Inflammatory markers
Changes in concentration of inflammatory markers
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
SCFA concentration
Changes in faecal concentration of short chain fatty acids
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Lipidomics and bile acids
Changes in concentration of lipids and bile acids in blood and faecal samples
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Metabolomics
Analyses of metabolites in blood, urine and fecal samples
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Weight loss
Interaction between differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group and each of baseline fasting glucose, baseline fasting insulin and baseline microbiome composition (e.g. enterotype).
Measured: Measurements will be performed at baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start26 May 2017
- Primary completion24 May 2018
- Study completion24 May 2018
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.
- More trials run by University of CopenhagenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, TNO, National Research Council, Spain
- Responsible party
- Principal investigator, Thomas Meinert Larsen, University of Copenhagen
- Investigators
- Thomas M Larsen, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135041
- Sponsor's protocol ID
- B328
- Acronym
- MNGII
- Status last verified
- May 2018
- First submitted
- 26 Apr 2017
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared personal data collected includes basic data and demographics as well as health related data (weight, blood pressure, medical history etc.) and biological samples including maximum 50 mL blood, faecal samples and spot urine collected at baseline and during the study. The blood samples collected will be used for the analyses of markers of glucose metabolism, lipid metabo-lism and inflammation. Urine collection will be used for metabolomics analyses. Faecal samples will be used for metagenomics analyses and analysis of bile acids. Biological samples will be stored in the research biobank for 5 years and destroyed afterwards. Link between participant number and personal identification will be separated and stored in one protected participant number log. Personal data will be stored for 5 years, where data will be anonymized by destroying basic data sheet and participant number log.
Publications
Hess AL, Benitez-Paez A, Blaedel T, Larsen LH, Iglesias JR, Madera C, Sanz Y, Larsen TM; MyNewGut Consortium. The effect of inulin and resistant maltodextrin on weight loss during energy restriction: a randomised, placebo-controlled, double-blinded intervention. Eur J Nutr. 2020 Sep;59(6):2507-2524. doi: 10.1007/s00394-019-02099-x. Epub 2019 Oct 11.
PubMed 31605197
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population
- ClinicalTrials.gov ID
- NCT03135041
- Acronym / sponsor ID
- MNGII / B328
- Conditions
- Obesity
- Keywords
- Prebiotics, Microbiome, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Reading, TNO, National Research Council, Spain
- Study start
- 26 May 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 1 May 2017 (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.
The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres induces greater changes in body weight compared to placebo during 12 weeks of energy restriction in an obese/overweight population.
The hypothesis is that the fiber-containing dietary supplement will:
- Induce greater changes in body weight compared to the placebo group 2) change the gut microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of triglycerides, total and LDL cholesterol
The hypothesis is that the effect of the intervention on weight loss will be partly mediated by the diet-induced changes in the gut microbiota composition.
Detailed description
Prebiotics are nutrients that specifically utilized by the gut microbiota. Beneficial health effects of prebiotics are generally attributed to 1) stimulation of beneficial bacteria and SCFA production, and consequently; improved barrier function, regulation of enteroendocrine peptide secretion and resistance to inflammatory stimuli; 2) modulation of lipid metabolism, possibly by suppression of lipogenic enzymes and thus decreased synthesis of lipoproteins and triglycerides; and 3) increased mineral absorption.
Inulin is recognized as a common prebiotic. Fibersol-2 is a resistant starch that has been suggested to induce satiety, when given in a dose of 10 g. Intake of inulin has been shown to induce changes in the microbial abundance and increase production of SCFA19; whereas resistant starch has been shown to improve insulin sensitivity and postprandial glucose AUC20. However, the effects of an intervention with a combination of these two fibers on obesity and body composition during an energy restricted diet have not been addressed. Supplements with other types of fibres in addition to energy restriction have shown additional effects in weight reduction.
In this study, the effects of a combination product of two prebiotic fibres on additional weight loss during energy restriction in a placebo-controlled, randomized parallel study with a duration of 12 weeks will be tested. Furthermore, the effects of the fibres on the gut microbial composition, markers of metabolic syndrome (MetS) and glucose metabolism will be tested. The active diet will contain intervention products high in dietary fibre and the placebo diet will contain maltodextrin. The fiber-containing dietary supplements will add approximately 20 g of prebiotic fibres per day, where approximately 10 g will be inulin and approximately 10 g will be resistant maltodextrin. The intervention products and placebo will be consumed as milk. The fiber-containing dietary supplement is expected to induce additional weight loss, compared to placebo and to affect the gut microbiome and markers of metabolic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber-containing dietary supplement | Experimental | Dietary Supplement: Fiber-containing dietary supplement2 x 200 ml of fiber-enriched UHT milk during 12 weeks of energy restriction |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 x 200 ml of UHT milk with maltodextrin during 12 weeks of energy restriction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI: 28-45 kg/m2
- Non-smoking
- Haemoglobin level ≥7 mmol/L
Key exclusion criteria (19 listed)
- Use of antibiotics three months prior to study and during the study. If a participant uses antibiotics prior to randomization, the participant will be invited to be re-screened 3 months after the last use of antibiotics, provided that it is realistic to complete the study no later than the scheduled LPLV
- Weight change >3 kg two months prior to study
- Blood donation other than for this study <1 month prior to study and during study.
- Participation in clinical trials other than for this <1 month prior to study and during study
- Intensive physical training/ elite athlete (>10 hours of strenuous physical activity per week)
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 |
|---|---|---|
| Fiber-containing dietary supplementEffects of fiber-containing dietary supplement on weight loss during energy restriction | Dietary supplement | Fiber-containing dietary supplement |
| PlaceboEffects of placebo supplement on weight loss during energy restriction | Dietary supplement | Placebo |
Primary outcome
Weight loss
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group
9 secondary outcomes
Body composition
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Gut microbiota composition and function
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Glucose metabolism
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Lipid metabolism
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Inflammatory markers
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
SCFA concentration
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Lipidomics and bile acids
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Metabolomics
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Weight loss
Time frame: Measurements will be performed at baseline and after 12 weeks of 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 29 May 2018.
- Derived from this study: PubMed 31605197Hess AL, Benitez-Paez A, Blaedel T, Larsen LH, Iglesias JR, Madera C, Sanz Y, Larsen TM; MyNewGut Consortium. The effect of inulin and resistant maltodextrin on weight loss during energy restriction: a randomised, placebo-controlled, double-blinded intervention. Eur J Nutr. 2020 Sep;59(6):2507-2524. doi: 10.1007/s00394-019-02099-x. Epub 2019 Oct 11.
- Individual participant dataSharing planned: Yes. Shared personal data collected includes basic data and demographics as well as health related data (weight, blood pressure, medical history etc.) and biological samples including maximum 50 mL blood, faecal samples and spot urine collected at baseline and during the study. The blood samples collected will be used for the analyses of markers of glucose metabolism, lipid metabo-lism and inflammation. Urine collection will be used for metabolomics analyses. Faecal samples will be used for metagenomics analyses and analysis of bile acids. Biological samples will be stored in the research biobank for 5 years and destroyed afterwards. Link between participant number and personal identification will be separated and stored in one protected participant number log. Personal data will be stored for 5 years, where data will be anonymized by destroying basic data sheet and participant number log.
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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.
Thomas M Larsen, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber-containing dietary supplement in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 19 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 29 May 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 Denmark. 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?
Weight loss (time frame: Measurements will be performed at baseline and after 12 weeks of 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 NCT03135041, 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 29 May 2018.