OverweightNCT02125955
Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
A study testing Prebiotic fiber in people with Overweight and Obesity, run by University of Calgary at 1 site in Canada.
Trial summary
Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Prebiotic fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Sep 2017
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys and girls between the ages of 7-12 years old
- BMI percentiles >85th percentile for their age and sex
- Tanner stage of ≤ 3, girls premenarche
Who cannot join
- Tanner stage of >3 or girls postmenarchal
- Use of antibiotics up to 3 months prior to study
- Regular prebiotic supplement and/or probiotic supplement use
- Subjects unable to provide consent (parental) or assent (child)
Trial locations and contacts
1 site in 1 country.
About this study
Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.
Read the detailed description
Obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. This is especially true for dietary fiber which has positive health benefits such as roles in weight management. A form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. The role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. The aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. Since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.
- Conditions
- Overweight, Obesity
- Being tested
- Prebiotic fiber, Placebo
- Keywords
- Pediatric, Overweight, Obesity, Gut microbiota, Adiposity, Prebiotic, Dietary fiber
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic fiberDietary supplement
Also called Synergy 1 (oligofructose enriched inulin)
Dissolved in water.
PlaceboDietary supplement
Also called Maltodextrin
Dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic fiber | Experimental | The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal. Receives: Dietary Supplement: Prebiotic fiber |
| Placebo | Placebo comparator | The placebo group will consume an isocaloric dose of placebo (maltodextrin; 3.3 grams) one time per day approximately 30 minutes prior to their evening meal. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
Measured: 16 weeks
Secondary outcomes (1)
Appetite regulation
Change in baseline appetite at 16 weeks. Subjective appetite assessed with visual analog scales and eating behavior questionnaire. Objective measures include a weighed breakfast buffet, weighted 3-day food records and serum satiety hormone levels.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionSep 2017
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 OverweightStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital
- Responsible party
- Principal investigator, Dr. Raylene Reimer, University of Calgary
- Investigators
- Raylene A Reimer, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125955
- Sponsor's protocol ID
- UC-1026386
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nicolucci AC, Hume MP, Martinez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. Epub 2017 Jun 5.
PubMed 28596023Hume MP, Nicolucci AC, Reimer RA. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):790-799. doi: 10.3945/ajcn.116.140947. Epub 2017 Feb 22.
PubMed 28228425
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT02125955
- Acronym / sponsor ID
- UC-1026386
- Conditions
- Overweight, Obesity
- Keywords
- Pediatric, Overweight, Obesity, Gut microbiota, Adiposity, Prebiotic, Dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Apr 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.
Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.
Detailed description
Obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. This is especially true for dietary fiber which has positive health benefits such as roles in weight management. A form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. The role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. The aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. Since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.
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 |
|---|---|---|
| Prebiotic fiber | Experimental | Dietary Supplement: Prebiotic fiberThe intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will consume an isocaloric dose of placebo (maltodextrin; 3.3 grams) one time per day approximately 30 minutes prior to their evening meal. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys and girls between the ages of 7-12 years old
- BMI percentiles >85th percentile for their age and sex
- Tanner stage of ≤ 3, girls premenarche
Key exclusion criteria (4 listed)
- Tanner stage of >3 or girls postmenarchal
- Use of antibiotics up to 3 months prior to study
- Regular prebiotic supplement and/or probiotic supplement use
- Subjects unable to provide consent (parental) or assent (child)
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 |
|---|---|---|
| Prebiotic fiberAlso: Synergy 1 (oligofructose enriched inulin)Dissolved in water. | Dietary supplement | Prebiotic fiber |
| PlaceboAlso: MaltodextrinDissolved in water | Dietary supplement | Placebo |
Primary outcome
Body fat
Time frame: 16 weeks
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
1 secondary outcome
Appetite regulation
Time frame: 16 weeks
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 26 Oct 2017.
- Results publication: PubMed 28596023Nicolucci AC, Hume MP, Martinez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. Epub 2017 Jun 5.
- Results publication: PubMed 28228425Hume MP, Nicolucci AC, Reimer RA. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):790-799. doi: 10.3945/ajcn.116.140947. Epub 2017 Feb 22.
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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.
Raylene A Reimer, PhD, RD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic fiber in people with Overweight and Obesity, run by University of Calgary at 1 site in Canada.
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 4 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 26 Oct 2017. 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 Canada. 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?
Body fat (time frame: 16 weeks). 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 NCT02125955, which also lists 2 linked publications.
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 26 Oct 2017.