Alcohol in the Treatment of Obesity
This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Duke University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00594074
First received: January 4, 2008
Last updated: June 3, 2008
Last verified: June 2008
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Purpose
This pilot study looks at the relationship of moderate alcohol consumption on weight loss.
| Condition | Intervention |
|---|---|
|
Obesity, Weight Loss, Alcohol Drinking |
Other: white wine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Alcohol in the Treatment of Obesity |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other: white wine
3.25 ounces of white wine with lunch and dinner
|
|
No Intervention: 2
This group receives the same amount of calories as the experimental group
|
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, NC. 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594074
Locations
| United States, North Carolina | |
| 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 |
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: | Richard S. Surwit, Ph.D., ABPP, FAClinP, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00594074 History of Changes |
| Other Study ID Numbers: | 7638 |
| Study First Received: | January 4, 2008 |
| Last Updated: | June 3, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alcohol Drinking Obesity Weight Loss Drinking Behavior Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 21, 2013