Study of Coffee Mannooligosaccharides for Weight Management

NCT ID: NCT00932750

Last Updated: 2012-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-11-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MOS Weight maintenance

Group Type: PLACEBO_COMPARATOR

Coffee mannooligosaccharide

Intervention Type: DIETARY_SUPPLEMENT

2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.

MOS weight loss

Group Type: PLACEBO_COMPARATOR

Coffee mannooligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo

Interventions

Coffee mannooligosaccharide

2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.

Intervention Type: DIETARY_SUPPLEMENT

Coffee mannooligosaccharides

Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

St. Luke's/Roosevelt Hospital

Principal Investigators

Marie-Pierre St-Onge, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

St. Luke's/Roosevelt Hospital

New York, New York, United States

Countries

United States

Other Identifiers

KF-MOS-01

Identifier Type: -

Identifier Source: org_study_id