Alcohol in the Treatment of Obesity

NCT ID: NCT00594074

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-07-31

Brief Summary

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

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.

Conditions

Obesity, Weight Loss, Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

This group will receive 3.25 ounces of white wine with lunch and dinner

Group Type: EXPERIMENTAL

white wine

Intervention Type: OTHER

3.25 ounces of white wine twice a day with lunch and dinner

2

This group receives the same amount of calories as the experimental group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

white wine

3.25 ounces of white wine twice a day with lunch and dinner

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard S Surwit, Ph.D., ABPP,

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Structure House, LLC

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

7638

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00008809

Identifier Type: -

Identifier Source: org_study_id