Obesity, Weight Loss, Alcohol DrinkingNCT00594074
Alcohol in the Treatment of Obesity
A study testing white wine in people with Obesity, Weight Loss, Alcohol Drinking, run by Duke University at 1 site in United States.
Trial summary
This pilot study looks at the relationship of moderate alcohol consumption on weight loss. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Alcohol Drinking
- What is being tested?
- white wine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study looks at the relationship of moderate alcohol consumption on weight loss.
Read the 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
- Being tested
- white wine
- Medical subject headings
- Obesity, Weight Loss, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white wineOther
3.25 ounces of white wine twice a day with lunch and dinner
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This group will receive 3.25 ounces of white wine with lunch and dinner Receives: Other: white wine |
| 2 | No intervention | This group receives the same amount of calories as the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, Weight Loss, Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard S Surwit, Ph.D., ABPP,, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594074
- Sponsor's protocol ID
- Pro00008809
- Other IDs
- 7638
- Status last verified
- Jul 2013
- First submitted
- 4 Jan 2008
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol in the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT00594074
- Acronym / sponsor ID
- Pro00008809
- Conditions
- Obesity, Weight Loss, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: white wineThis group will receive 3.25 ounces of white wine with lunch and dinner |
| 2 | No intervention | –This group receives the same amount of calories as the experimental group |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white wine3.25 ounces of white wine twice a day with lunch and dinner | Other | 1 |
Primary outcome
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
1 secondary outcome
Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner.
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- BackgroundAjani, 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard S Surwit, Ph.D., ABPP, principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white wine in people with Obesity, Weight Loss, Alcohol Drinking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.