OverweightPhase 2NCT00974831
Glucose Tolerance in Healthy Overweight Adults
A Phase 2 study testing Amino Acid Drink Mixture and Glucose drink in people with Overweight, run by Abbott Nutrition at 1 site in United States.
Trial summary
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Amino Acid Drink Mixture and Glucose drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 2
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
- Subject states that he/she does not have type 1 or 2 diabetes.
- Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
- Subject's BMI is ≥ 25 kg/m2.
- Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic.
- Subject is between 20 and 45 years of age, inclusive.
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- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing birth control
- If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.
Who cannot join
- Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
- Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy.
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end-stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
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- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol.
- Subject states that he/she has clotting or bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.
- Conditions
- Overweight
- Being tested
- Amino Acid Drink Mixture, Glucose drink
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid Drink MixtureOther
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Glucose drinkOther
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
| Study group | Role | What they receive |
|---|---|---|
| AA Drink | Experimental | Amino Acid Drink Mixture Receives: Other: Amino Acid Drink Mixture |
| Glucose drink | Placebo comparator | Not described Receives: Other: Glucose drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
Measured: 0-180 minutes
Secondary outcomes (1)
Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Nelson, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974831
- Sponsor's protocol ID
- BK51
- Status last verified
- Nov 2009
- First submitted
- 9 Sep 2009
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Tolerance in Healthy Overweight Adults
- ClinicalTrials.gov ID
- NCT00974831
- Acronym / sponsor ID
- BK51
- Conditions
- Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Sep 2009 (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.
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA Drink | Experimental | Other: Amino Acid Drink MixtureAmino Acid Drink Mixture |
| Glucose drink | Placebo comparator | Other: Glucose drink |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
- Subject states that he/she does not have type 1 or 2 diabetes.
- Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
- Subject's BMI is ≥ 25 kg/m2.
- Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic.
Key exclusion criteria (11 listed)
- Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
- Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy.
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end-stage organ failure or is status post organ transplant.
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 |
|---|---|---|
| Amino Acid Drink Mixture22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins | Other | AA Drink |
| Glucose drink22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins | Other | Glucose drink |
Primary outcome
The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
Time frame: 0-180 minutes
1 secondary outcome
Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time
Time frame: 0-180 minutes
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 25 Nov 2010.
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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.
Jeffrey Nelson, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amino Acid Drink Mixture and Glucose drink in people with Overweight, run by Abbott Nutrition 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 9 inclusion and 11 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 25 Nov 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 variable is the positive area under the curve from 0 to 180 minutes for plasma glucose. (time frame: 0-180 minutes). 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 25 Nov 2010.