Study of Coffee Mannooligosaccharides for Weight Management (MOS)

August 21, 2012 updated by: Mondelēz International, Inc.

THE EFFECTS OF COFFEE MANNOOLIGOSACCHARIDES ON INDICES OF BODY WEIGHT, BODY COMPOSITION, AND SATIETY IN HUMANS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's/Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: MOS Weight maintenance
Dietary supplement: Coffee mannooligosaccharide
2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.
Placebo Comparator: MOS weight loss
Dietary supplement: Coffee mannooligosaccharides
Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Composition by Magnetic Resonance Imaging
Time Frame: Baseline and Endpoint
Baseline and Endpoint
Blood pressure
Time Frame: Weekly
Weekly
Body weight
Time Frame: Weekly
Weekly
Waist circumference
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Appetite/Satiety
Time Frame: Weekly
Weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mondelēz International, Inc.

Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D, St. Luke's-Roosevelt Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KF-MOS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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