Study of Coffee Mannooligosaccharides for Weight Management (MOS)

This study has been completed.
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by:
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT00932750
First received: July 2, 2009
Last updated: August 21, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932750

Locations
United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
Mondelēz International, Inc.
St. Luke's-Roosevelt Hospital Center
Investigators
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 August 20, 2014