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Study of Coffee Mannooligosaccharides for Weight Management

NCT ID: NCT00932750

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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Obesity

Keywords

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Body composition Weight loss Weight management Beverages Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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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

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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St. Luke's/Roosevelt Hospital

Principal Investigators

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Marie-Pierre St-Onge, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

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St. Luke's/Roosevelt Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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KF-MOS-01

Identifier Type: -

Identifier Source: org_study_id