Expired Study
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Durham, North Carolina 27705


Purpose:

This pilot study looks at the relationship of moderate alcohol consumption on weight loss.


Study summary:

We hypothesize that individuals who consume a moderate amount of alcohol, such as a glass or two of wine daily, will lose more during a weight-reduction program than will those who do not, if equal calories are administered to both groups. The purpose of this pilot study is to look at the relationship of alcohol in weight loss. The current standard in weight loss programs is to eliminate alcohol from the diet. We propose to enroll 50 females enrolled at the Structure House residential diet program in Durham, North Carolina. Half or the subjects will receive 150 calories in the form of white wine, 3.5 ounce with lunch and 3.5 ounces with dinner. The other half of the subjects wil receive their 150 calories in their regular diet. All participants are asked not to consume any additional alcohol. Participants will be weighed daily. The study lasts four weeks.


Criteria:

Inclusion Criteria: - Age >21, female, BMI ≥ 30, no history of substance abuse, prior alcohol use of at least one drink/week; Exclusion: - pregnancy, breast feeding, previous history of alcohol abuse, liver disease.


Study is Available At:


Original ID:

Pro00008809


NCT ID:

NCT00594074


Secondary ID:

7638


Study Acronym:


Brief Title:

Alcohol in the Treatment of Obesity


Official Title:

Alcohol in the Treatment of Obesity


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Female


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Unable to recruit subjects


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard S Surwit, Ph.D., ABPP,
Principal Investigator
Duke University

Study Dates

Start Date:April 2007
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 23, 2013
First Received Date:January 4, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner.
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:An outcome measure for the study is an increase weight loss or no change in the wine group of .05% over the 4 weeks of the study
Time Frame:4 weeks
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:white wine
Description:3.25 ounces of white wine twice a day with lunch and dinner
Arm Name:1

Study Arms

Study Arm Type:No Intervention
Arm Name:2
Description:This group receives the same amount of calories as the experimental group
Study Arm Type:Experimental
Arm Name:1
Description:This group will receive 3.25 ounces of white wine with lunch and dinner

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Ajani, U. A., Hennekens, C. H., Spelsberg, A., & Manson, J. E. (2000). Alcohol consumption and risk of type 2 diabetes mellitus among US male physicians. Arch Intern Med, 160(7), 1025-1030. Dallongeville, J., Marecaux, N., Ducimetiere, P., Ferrieres, J., Arveiler, D., Bingham, A., et al. (1998). Influence of alcohol consumption and various beverages on waist girth and waist-to-hip ratio in a sample of French men and women. Int J Obes Relat Metab Disord, 22(12), 1178-1183. Flechtner-Mors, M., Biesalski, H. K., Jenkinson, C. P., Adler, G., & Ditschuneit, H. H. (2004). Effects of moderate consumption of white wine on weight loss in overweight and obese subjects. Int J Obes Relat Metab Disord, 28(11), 1420-1426. Melanson, K. & Dwyer, J. (2002). Popular diets for treatment of overweight and obesity. In T. A. S. Wadden, A. J. (Ed.), Handbook of obesity treatment (2 ed., pp. 249-282). New York: The Guilford Press. Rimm, E. B., Chan, J., Stampfer, M. J., Colditz, G. A., & Wille

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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