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Clinical Trials/NCT00932750
NCT00932750CompletedNot Applicable

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

Mondelēz International, Inc.1 site in 1 country82 target enrollmentStarted: September 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
82
Locations
1
Primary Endpoint
Blood pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Blood pressure

Time Frame: Weekly

Body weight

Time Frame: Weekly

Body Composition by Magnetic Resonance Imaging

Time Frame: Baseline and Endpoint

Waist circumference

Time Frame: Weekly

Secondary Outcomes

  • Appetite/Satiety(Weekly)

Investigators

Sponsor
Mondelēz International, Inc.
Sponsor Class
Industry

Study Sites (1)

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