Alcohol in the Treatment of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594074
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : January 15, 2008
Last Update Posted : July 25, 2013
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Obesity, Weight Loss, Alcohol Drinking Other: white wine Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Alcohol in the Treatment of Obesity
Study Start Date : April 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
This group will receive 3.25 ounces of white wine with lunch and dinner
Other: white wine
3.25 ounces of white wine twice a day with lunch and dinner
No Intervention: 2
This group receives the same amount of calories as the experimental group

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner. [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594074

United States, North Carolina
Structure House, LLC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Richard S Surwit, Ph.D., ABPP, Duke University

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., & Willett, W. C. (1995). Prospective study of cigarette smoking, alcohol use, and the risk of diabetes in men. Bmj, 310(6979), 555-559. Stampfer, M. J., Colditz, G. A., Willett, W. C., Manson, J. E., Arky, R. A., Hennekens, C. H., et al. (1988). A prospective study of moderate alcohol drinking and risk of diabetes in women. Am J Epidemiol, 128(3), 549-558. Wannamethee, S. G., Camargo, C. A., Jr., Manson, J. E., Willett, W. C., & Rimm, E. B. (2003). Alcohol drinking patterns and risk of type 2 diabetes mellitus among younger women. Arch Intern Med, 163(11), 1329-1336. Wannamethee, S. G., Field, A. E., Colditz, G. A., & Rimm, E. B. (2004). Alcohol intake and 8-year weight gain in women: a prospective study. Obes Res, 12(9), 1386-1396.

Responsible Party: Duke University Identifier: NCT00594074     History of Changes
Other Study ID Numbers: Pro00008809
7638 ( Other Identifier: DUMC )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Weight Loss
Alcohol Drinking
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Drinking Behavior