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

University of Calgary

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Control; Dietary Supplement: Protein; Dietary Supplement: Prebiotic fiber; Dietary Supplement: Protein plus prebiotic fiber

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02217579

UofC Protocol REB13-0169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Isocaloric food without the test protein and prebiotic fiber.

Treatment:

Dietary Supplement: Control

Protein

Experimental group

Description:

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

Treatment:

Dietary Supplement: Protein

Fiber

Experimental group

Description:

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

Treatment:

Dietary Supplement: Prebiotic fiber

Protein plus prebiotic fiber

Experimental group

Description:

Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.

Treatment:

Dietary Supplement: Protein plus prebiotic fiber