Alcohol in the Treatment of Obesity

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00594074
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Apr 1, 2007
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

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 [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. [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Structure House, LLC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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
• ClinicalTrials.gov Identifier: NCT00594074
• Other Study ID Numbers: Pro00008809; 7638
• First Posted: Jan 15, 2008
• Last Update Posted: Jul 25, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Obesity; Weight Loss; Alcohol Drinking

Study Results

No Results Posted as of Jul 25, 2013