NCT00932750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

July 2, 2009

Last Update Submit

August 21, 2012

Conditions

Obesity

Keywords

Body compositionWeight lossWeight managementBeveragesDiet

Outcome Measures

Primary Outcomes (4)

  • Body Composition by Magnetic Resonance Imaging

    Baseline and Endpoint

  • Blood pressure

    Weekly

  • Body weight

    Weekly

  • Waist circumference

    Weekly

Secondary Outcomes (1)

  • Appetite/Satiety

    Weekly

Study Arms (2)

MOS Weight maintenance

PLACEBO COMPARATOR
Dietary Supplement: Coffee mannooligosaccharide

MOS weight loss

PLACEBO COMPARATOR
Dietary Supplement: Coffee mannooligosaccharides

Interventions

Coffee mannooligosaccharideDIETARY_SUPPLEMENT

2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.

MOS Weight maintenance
Coffee mannooligosaccharidesDIETARY_SUPPLEMENT

Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo

MOS weight loss

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index 27-33 kg/m2
  • Stable body weight

You may not qualify if:

  • Body width \> 46 cm
  • Medications known to affect body weight, lipids, blood pressure
  • Pregnant or lactating women
  • Less than 1 y post-partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's/Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Marie-Pierre St-Onge, Ph.D

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

September 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

US(1)