NCT02217579

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

August 13, 2014

Last Update Submit

October 24, 2017

Conditions

Obesity

Keywords

Weight lossAppetiteOverweightObesityDietary fiberDietary protein

Outcome Measures

Primary Outcomes (1)

  • Change in baseline fat mass at 12 weeks

    Assessed with dual energy x-ray absorptiometry.

    12 weeks

Secondary Outcomes (1)

  • Change in baseline appetite at 12 weeks

    12 weeks

Other Outcomes (2)

  • Change in baseline quality of life rating at 12 weeks

    12 weeks

  • Change in baseline gut microbiota at 12 weeks

    12 weeks

Study Arms (4)

Control

PLACEBO COMPARATOR

Isocaloric food without the test protein and prebiotic fiber.

Dietary Supplement: Control

Protein

EXPERIMENTAL

Dietary protein consumed as two daily servings of 5 grams protein/serving.

Dietary Supplement: Protein

Fiber

EXPERIMENTAL

Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.

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.

Dietary Supplement: Protein plus prebiotic fiber

Interventions

ProteinDIETARY_SUPPLEMENT

A food containing 5 grams/serving of supplemental protein.

Protein
Prebiotic fiberDIETARY_SUPPLEMENT

A food containing 8 grams/serving of supplemental prebiotic fiber.

Fiber
Protein plus prebiotic fiberDIETARY_SUPPLEMENT

A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).

Protein plus prebiotic fiber
ControlDIETARY_SUPPLEMENT

An isocaloric food not containing the test protein and fiber.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28730743RESULT

MeSH Terms

Conditions

ObesityWeight LossOverweight

Interventions

Proteins

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Raylene A Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

August 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)