ObesityNCT02217579
Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
A study testing Protein, Prebiotic fiber and Protein plus prebiotic fiber in people with Obesity, run by University of Calgary at 1 site in Canada.
Trial summary
The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Protein, Prebiotic fiber and Protein plus prebiotic fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Aug 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- Age 18 - 70 years
- BMI 25 - 38 kg/m-2
- Stable body weight for at least 3 months prior to the study
Who cannot join
- Type 1 diabetes
- Clinically significant cardiovascular, liver or pancreas disease
- Major gastrointestinal surgeries
- Pregnant or lactating
- Concomitant use of any weight loss medication, diet or exercise regime
- Antibiotic use in the preceding 3 months to enrollment
- Weight loss > 3 kg within preceding 3 months to enrollment
- Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
Trial locations and contacts
1 site in 1 country.
About this study
The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.
Read the detailed description
The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population.
Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat.
Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake.
Other outcomes includes changes in quality of life ratings and gut microbiota.
- Conditions
- Obesity
- Being tested
- Protein, Prebiotic fiber, Protein plus prebiotic fiber, Control
- Keywords
- Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein
- Medical subject headings
- Obesity, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
A food containing 5 grams/serving of supplemental protein.
Prebiotic fiberDietary supplement
A food containing 8 grams/serving of supplemental prebiotic fiber.
Protein plus prebiotic fiberDietary supplement
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
ControlDietary supplement
An isocaloric food not containing the test protein and fiber.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Isocaloric food without the test protein and prebiotic fiber. Receives: Dietary Supplement: Control |
| Protein | Experimental | Dietary protein consumed as two daily servings of 5 grams protein/serving. Receives: Dietary Supplement: Protein |
| Fiber | Experimental | Prebiotic fiber consumed as two daily servings of 8 grams protein/serving. Receives: Dietary Supplement: Prebiotic fiber |
| Protein plus prebiotic fiber | Experimental | Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving. Receives: Dietary Supplement: Protein plus prebiotic fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline fat mass at 12 weeks
Assessed with dual energy x-ray absorptiometry.
Measured: 12 weeks
Secondary outcomes (1)
Change in baseline appetite at 12 weeks
Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionAug 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- 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
- NCT02217579
- Sponsor's protocol ID
- UofC Protocol REB13-0169
- Status last verified
- Oct 2017
- First submitted
- 13 Aug 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.
PubMed 28730743
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 Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT02217579
- Acronym / sponsor ID
- UofC Protocol REB13-0169
- Conditions
- Obesity
- Keywords
- Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Aug 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.
The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.
Detailed description
The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population.
Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat.
Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake.
Other outcomes includes changes in quality of life ratings and gut microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlIsocaloric food without the test protein and prebiotic fiber. |
| Protein | Experimental | Dietary Supplement: ProteinDietary protein consumed as two daily servings of 5 grams protein/serving. |
| Fiber | Experimental | Dietary Supplement: Prebiotic fiberPrebiotic fiber consumed as two daily servings of 8 grams protein/serving. |
| Protein plus prebiotic fiber | Experimental | Dietary Supplement: Protein plus prebiotic fiberProtein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- Age 18 - 70 years
- BMI 25 - 38 kg/m-2
- Stable body weight for at least 3 months prior to the study
Key exclusion criteria (8 listed)
- Type 1 diabetes
- Clinically significant cardiovascular, liver or pancreas disease
- Major gastrointestinal surgeries
- Pregnant or lactating
- Concomitant use of any weight loss medication, diet or exercise regime
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 |
|---|---|---|
| ProteinA food containing 5 grams/serving of supplemental protein. | Dietary supplement | Protein |
| Prebiotic fiberA food containing 8 grams/serving of supplemental prebiotic fiber. | Dietary supplement | Fiber |
| Protein plus prebiotic fiberA food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving). | Dietary supplement | Protein plus prebiotic fiber |
| ControlAn isocaloric food not containing the test protein and fiber. | Dietary supplement | Control |
Primary outcome
Change in baseline fat mass at 12 weeks
Time frame: 12 weeks
Assessed with dual energy x-ray absorptiometry.
1 secondary outcome
Change in baseline appetite at 12 weeks
Time frame: 12 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 28730743Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.
- Individual participant dataSharing planned: No
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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 Protein, Prebiotic fiber and Protein plus prebiotic fiber in people with 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 4 inclusion and 8 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?
Change in baseline fat mass at 12 weeks (time frame: 12 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 NCT02217579, 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 26 Oct 2017.