LeanNCT00523861
Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying
A study testing Moderate alcohol consumption in people with Lean and Obese, run by TNO at 1 site in Netherlands.
Trial summary
Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- What is being tested?
- Moderate alcohol consumption
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2005to Jun 2005
- 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 18 to 40 years
- Men only
- Adult
Who may be able to join
- Healthy as assessed by the:
- physical examination
- results of the pre-study laboratory tests
- Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
- Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
- Alcohol consumption between 7 and 28 units/week (including 7 and 28)
- Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire
Who cannot join
- Smoking
- Not willing or able to change habitual alcohol consumption during the study according to protocol
- Having an allergy for paracetamol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men
Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.
Read the detailed description
Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.
Design: Randomized, partially diet-controlled, placebo controlled cross-over design.
Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).
Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.
Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day
Measures:
- Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
- Gastric emptying and postprandial wellness.
- Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)
- Being tested
- Moderate alcohol consumption
- Keywords
- Glucose, Insulin sensitivity, Glucose metabolism, Appetite, Satiety
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate alcohol consumptionDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage
Measured: 3 weeks
Secondary outcomes (1)
Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeanStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Investigators
- Henk FJ Hendriks, PhD, Principal investigator, Hendriks HFJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523861
- Sponsor's protocol ID
- P6281
- Other IDs
- Alcohol Research 19
- Status last verified
- Aug 2007
- First submitted
- 30 Aug 2007
- Last updated
- 14 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men
- ClinicalTrials.gov ID
- NCT00523861
- Acronym / sponsor ID
- P6281
- Keywords
- Glucose, Insulin sensitivity, Glucose metabolism, Appetite, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Jun 2005 (actual)
- First posted
- 3 Sep 2007 (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.
Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.
Detailed description
Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.
Design: Randomized, partially diet-controlled, placebo controlled cross-over design.
Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).
Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.
Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day
Measures:
- Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
- Gastric emptying and postprandial wellness.
- Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as assessed by the:
- physical examination
- results of the pre-study laboratory tests
- Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
- Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
Key exclusion criteria (3 listed)
- Smoking
- Not willing or able to change habitual alcohol consumption during the study according to protocol
- Having an allergy for paracetamol
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 |
|---|---|---|
| Moderate alcohol consumption | Dietary supplement | – |
Primary outcome
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage
Time frame: 3 weeks
1 secondary outcome
Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2007.
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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.
Henk FJ Hendriks, PhD principal investigator
Hendriks HFJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate alcohol consumption in people with Lean and Obese, run by TNO at 1 site in Netherlands.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 14 Sep 2007. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2007.