Obesity, ChildhoodPhase 3NCT04578652
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
A Phase 3 study testing Metformin 850 mg oral tablet bid and Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX. in people with Obesity, Childhood and Insulin Resistance, run by University of Alberta at 1 site in Canada.
Trial summary
This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance [IR]), inflammation and BMI in adolescents with obesity and… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Childhood, Insulin Resistance
- What is being tested?
- Metformin 850 mg oral tablet bid and Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2021to Feb 2027
- Phase
- Phase 3
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-18 years
- BMI percentile > 95% for age/sex;
- Total weight fluctuation over past 6 months < 10%;
- HOMA-IR > 3.16;
- FH of T2DM (first or second-degree relative).
Who cannot join
- Current use of insulin or diagnosis of T2DM;
- Systolic or diastolic blood pressure (BP) > 99th percentile for age and sex;
- Acute infectious or inflammatory condition over the preceding 1 month; hospitalization > 48 hrs;
- History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders;
- Active malignancy;
- Concomitant use of medication/investigational drug known to affect body weight in the past year;
- Antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in the past 30 days; use of lipid-lowering and anti-inflammatory medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2E1
Andrea M Haqq, MD, MHS, 780-492-0015, haqq@ualberta.ca
Andrea M Haqq, MD, MHS
About this study
Official title: Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance [IR]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function.
Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM.
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- Conditions
- Obesity, Childhood, Insulin Resistance
- Being tested
- Metformin 850 mg oral tablet bid, Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.
- Keywords
- Dietary fiber, Metformin
- Medical subject headings
- Pediatric Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 850 mg oral tablet bidDrug
MET dose: 500 mg daily, increasing to 500 bid if tolerated after 2 weeks, then increasing again 2 weeks later to 850 mg bid (1700 mg daily).
Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.Dietary supplement
The first week of treatment will use 1/3 the daily treatment dose; then 2/3 dose for the second and third weeks; then the full dose thereafter, to allow time for adaptation.
| Study group | Role | What they receive |
|---|---|---|
| MET | Active comparator | MET (850 mg po bid - standard of care) + Fiber placebo daily Receives: Drug: Metformin 850 mg oral tablet bid |
| FIBER | Active comparator | Fiber supplementation [35g fiber daily] + MET placebo po bid Receives: Dietary Supplement: Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX. |
| FIBER + MET | Experimental | Fiber supplementation [35g fiber daily] + MET 850 mg po bid Receives: Drug: Metformin 850 mg oral tablet bid; Dietary Supplement: Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HOMA-IR
Change in HOMA-IR value
Measured: Baseline, 6, and 12 months
Secondary outcomes (11)
Changes in body weight
Body weight measured in kg
Measured: Baseline, 6, and 12 months
Changes in body mass index (BMI)
BMI percentile and z-score according to age and sex will be estimated
Measured: Baseline, 6, and 12 months
Changes in body composition
Body density using air-displacement plethysmography will be assessed to estimate fat mass and fat-free mass.
Measured: Baseline, 6, and 12 months
Changes in inflammation
Markers of inflammation that will be measured are: high-sensitivity C-reactive protein, interleukin, tumor necrosis factor-alpha)
Measured: Baseline, 6, and 12 months
Changes in metabolic function
The markers of metabolic function that will be measured are: fasting glucose, lipids (total, high and low density lipoprotein cholesterol; triglycerides), and oral glucose tolerance test.
Measured: Baseline, 6, and 12 months
Changes in satiety hormones
Markers of satiety that will be measured are: acylated ghrelin, peptide tyrosine tyrosine, GLP-1, leptin, and adiponectin.
Measured: Baseline, 6, and 12 months
Changes in quality of life
Quality of life will be measured by the a questionnaire
Measured: Baseline, 6, and 12 months
Changes in perceived hunger and satiety
Perceived hunger and satiety will be assessed by a questionnaire
Measured: Baseline, 6, and 12 months
Changes in gut microbiota composition
Fecal microbiota composition will be characterized by 16S rRNA gene amplicons sequencing using taxonomic and non-taxonomic based approaches.
Measured: Baseline, 6, and 12 months
Changes in gut microbiome functions
Fecal microbiome functions will be assessed through whole metagenomic sequencing, stool SCFAs and bile acids, and plasma metabolomics.
Measured: Baseline, 6, and 12 months
Changes in intestinal barrier integrity
Plasma lipopolysaccharide-binding protein and fecal calprotectin will be determined as measures of gut barrier integrity
Measured: Baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start22 Oct 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea M Haqq, MD, MHS, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578652
- Sponsor's protocol ID
- RN. # 414120
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fahim SM, Huey SL, Palma Molina XE, Agarwal N, Ridwan P, Ji N, Kibbee M, Kuriyan R, Finkelstein JL, Mehta S. Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years. Cochrane Database Syst Rev. 2025 Jul 10;7(7):CD015875. doi: 10.1002/14651858.CD015875.
PubMed 40637175Deehan EC, Colin-Ramirez E, Triador L, Madsen KL, Prado CM, Field CJ, Ball GDC, Tan Q, Orsso C, Dinu I, Pakseresht M, Rubin D, Sharma AM, Tun H, Walter J, Newgard CB, Freemark M, Wine E, Haqq AM. Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial. Trials. 2021 Feb 17;22(1):148. doi: 10.1186/s13063-021-05060-8.
PubMed 33596993