ObesityNCT03003897
Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.
An observational study of Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Soluble Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 609 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed chronic disease at screening.
Who may be able to join
- Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review and meta-analysis if they involve participants who are:
- Overweight or obese (BMI ≥ 25.0 kg/m2 for U.S. populations and ≥ 23.0 kg/m2 for Asian populations and/or waist circumference ≥ 40 inches (94 cm) in men or ≥ 35 inches (80 cm) in women and/or waist-to-hip ratio ≥ 0.90 in men or ≥ 0.85 in women).
- Weight stable and not actively trying to lose weight at screening.
- Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia, hypertension, type 2 diabetes, and cardiovascular disease).
- Included studies will be soluble fiber supplementation interventions that are controlled feeding studies or conducted among free-living subjects that provide data for outcomes of interest.
Who cannot join
- Studies will be excluded from the systematic review and meta-analysis if they meet any of the following criteria:
- Studies conducted in animals.
- Mechanistic research.
- Human trials involving pregnant women, breastfeeding women, or children.
- Conference proceedings.
- Articles not published in English.
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- Studies less than 1 week in duration.
- Studies that pool outcome measure data for healthy weight and overweight and obese individuals.
- Studies involving whole food treatments or high fiber profile diets.
- Weight loss interventions involving other tactics, such as counseling or energy restriction.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Effects of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Adults With Overweight and Obesity: a Systematic Review and Meta-analysis of Randomized Controlled Trials.
Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance [HOMA-IR], fasting insulin) through systematic review and meta-analysis.
- Conditions
- Obesity
- Being tested
- Soluble Fiber, Placebo
- Keywords
- Dietary Fiber, Soluble Fiber, Body Mass Index, Body Weight, Blood Glucose, Insulin
- Medical subject headings
- Obesity, Body Weight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble FiberOther
Participants receiving soluble fiber.
PlaceboOther
Participants receiving placebo.
| Study group | Role | What they receive |
|---|---|---|
| Soluble Fiber Treatment | Participants receiving soluble fiber. Receives: Other: Soluble Fiber | |
| Placebo Treatment | Participants receiving placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (kg/m2)
Measured: ≥ 1 week
Body weight (kg)
Measured: ≥ 1 week
Body fat (% fat mass)
Measured: ≥ 1 week
Waist circumference (cm)
Measured: ≥ 1 week
Fasting glucose (mmol/l)
Measured: ≥ 1 week
Fasting insulin (pmol/l)
Measured: ≥ 1 week
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Measured: ≥ 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionOct 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003897
- Sponsor's protocol ID
- Soluble Fiber Review
- Status last verified
- Jul 2018
- First submitted
- 28 Oct 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data has been previously published in the randomized controlled trials we intend to analyze.
Publications
Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.
PubMed 29092878
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Adults With Overweight and Obesity: a Systematic Review and Meta-analysis of Randomized Controlled Trials.
- ClinicalTrials.gov ID
- NCT03003897
- Acronym / sponsor ID
- Soluble Fiber Review
- Conditions
- Obesity
- Keywords
- Dietary Fiber, Soluble Fiber, Body Mass Index, Body Weight, Blood Glucose, Insulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Dec 2016 (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.
Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance [HOMA-IR], fasting insulin) through systematic review and meta-analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soluble Fiber Treatment | – | Other: Soluble FiberParticipants receiving soluble fiber. |
| Placebo Treatment | – | Other: PlaceboParticipants receiving placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed chronic disease at screening.
Key inclusion criteria (5 listed)
- Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review and meta-analysis if they involve participants who are:
- Overweight or obese (BMI ≥ 25.0 kg/m2 for U.S. populations and ≥ 23.0 kg/m2 for Asian populations and/or waist circumference ≥ 40 inches (94 cm) in men or ≥ 35 inches (80 cm) in women and/or waist-to-hip ratio ≥ 0.90 in men or ≥ 0.85 in women).
- Weight stable and not actively trying to lose weight at screening.
- Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia, hypertension, type 2 diabetes, and cardiovascular disease).
- Included studies will be soluble fiber supplementation interventions that are controlled feeding studies or conducted among free-living subjects that provide data for outcomes of interest.
Key exclusion criteria (10 listed)
- Studies will be excluded from the systematic review and meta-analysis if they meet any of the following criteria:
- Studies conducted in animals.
- Mechanistic research.
- Human trials involving pregnant women, breastfeeding women, or children.
- Conference proceedings.
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 |
|---|---|---|
| Soluble FiberParticipants receiving soluble fiber. | Other | Soluble Fiber Treatment |
| PlaceboParticipants receiving placebo. | Other | Placebo Treatment |
Primary outcome
Body mass index (kg/m2)
Time frame: ≥ 1 week
Body weight (kg)
Time frame: ≥ 1 week
Body fat (% fat mass)
Time frame: ≥ 1 week
Waist circumference (cm)
Time frame: ≥ 1 week
Fasting glucose (mmol/l)
Time frame: ≥ 1 week
Fasting insulin (pmol/l)
Time frame: ≥ 1 week
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: ≥ 1 week
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 Jul 2018.
- Results publication: PubMed 29092878Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.
- Individual participant dataSharing planned: No. Individual participant data has been previously published in the randomized controlled trials we intend to analyze.
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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.
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?
An observational study of Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 5 inclusion and 10 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 Jul 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 United States. 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. 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 mass index (kg/m2) (time frame: ≥ 1 week). The study lists 7 primary outcomes in all. 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 NCT03003897, 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 Jul 2018.