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OpenTrials
Completed

NCT Number: NCT02217579

Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Protein

Dietary Supplement

A food containing 5 grams/serving of supplemental protein.

Prebiotic fiber

Dietary Supplement

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

Protein plus prebiotic fiber

Dietary Supplement

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

Control

Dietary Supplement

An isocaloric food not containing the test protein and fiber.

Primary outcomes

  1. Change in baseline fat mass at 12 weeks

    Time frame: 12 weeks

    Assessed with dual energy x-ray absorptiometry.

Secondary outcomes

  1. Change in baseline appetite at 12 weeks

    Time frame: 12 weeks

    Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.

Other outcomes

  1. Change in baseline quality of life rating at 12 weeks

    Time frame: 12 weeks

    Measured with SF-36 questionnaire

  2. Change in baseline gut microbiota at 12 weeks

    Time frame: 12 weeks

    Measured by high throughput sequencing

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • General Mills

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Aug 15, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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