Study of Coffee Mannooligosaccharides for Weight Management (MOS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Dietary Supplement: Coffee mannooligosaccharide Dietary Supplement: Coffee mannooligosaccharides |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | THE EFFECTS OF COFFEE MANNOOLIGOSACCHARIDES ON INDICES OF BODY WEIGHT, BODY COMPOSITION, AND SATIETY IN HUMANS |
- Body Composition by Magnetic Resonance Imaging [ Time Frame: Baseline and Endpoint ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Appetite/Satiety [ Time Frame: Weekly ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, New York | |
| St. Luke's/Roosevelt Hospital | |
| New York, New York, United States, 10025 | |
| Principal Investigator: | Marie-Pierre St-Onge, Ph.D | St. Luke's-Roosevelt Hospital Center |
More Information
No publications provided
| Responsible Party: | Marie-Pierre St-Onge, Ph.D Research Associate, St. Luke's/Roosevelt Hospital |
| ClinicalTrials.gov Identifier: | NCT00932750 History of Changes |
| Other Study ID Numbers: | KF-MOS-01 |
| Study First Received: | July 2, 2009 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mondelēz International, Inc.:
|
Body composition Weight loss Weight management Beverages Diet |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013