Study of Coffee Mannooligosaccharides for Weight Management

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Coffee mannooligosaccharide; Dietary Supplement: Coffee mannooligosaccharides

• Registration Number: NCT00932750
• Lead Sponsor: Mondelēz International, Inc.

Brief Summary

The goal of this study is to establish the role of coffee mannooligosaccharides (MOS), provided in a beverage format, on body weight regulation. Overweight and obese men and women will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and safe. In the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. They will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. An 8-week washout period will follow during which time they will not be required to consume the beverages. The second phase of the study will be a weight loss phase. For this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. During this phase, they will undergo group counseling on a weekly basis. Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each phase. This study will allow us to determine whether MOS helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). The results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Body mass index 27-33 kg/m2
• Stable body weight

Exclusion Criteria

• Body width > 46 cm
• Medications known to affect body weight, lipids, blood pressure
• Pregnant or lactating women
• Less than 1 y post-partum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOS Weight maintenance	Coffee mannooligosaccharide	-
MOS weight loss	Coffee mannooligosaccharides	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	Weekly
Body weight	Weekly
Body Composition by Magnetic Resonance Imaging	Baseline and Endpoint
Waist circumference	Weekly

Secondary Outcome Measures

Name	Time	Method
Appetite/Satiety	Weekly

Trial Locations

Locations (1)

St. Luke's/Roosevelt Hospital; 🇺🇸 New York, New York, United States