Glucose BloodPhase 1NCT01516333
Replace Glycemic Load and Satiety Study
A Phase 1 study testing High GL 107, Medium GL 76 and Medium GL 68 in people with Glucose Blood and Glycemic Index, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Blood, Glycemic Index
- What is being tested?
- High GL 107, Medium GL 76 and Medium GL 68
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2007
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass index between 25-35 kg/m2
- Fasting serum glucose
- Fasting serum glucose < 125 mg/dl
- Free of chronic disease
- Willing to eat only the foods that are provided by the Center during the diet periods
- Willing to abstain from the consumption of alcohol during the diet periods
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- Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
- Monophasic birth control (same dose each day)
- Hormone replacement therapy
- Post-menopausal (over 1 year without bleeding)
- Have had partial hysterectomy over the age of 55
- complete hysterectomy at any age
Who cannot join
- Documented presence of atherosclerotic disease
- Diabetes mellitus
- Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
- Body Mass Index <25 or > 35
- History of drug or alcohol abuse in the last year
- For women, pregnancy, breast feeding or postpartum < 6 months
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- History of depression or mental illness requiring treatment or medication within that last 6 months
- Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
- Lifestyle or schedule incompatible with the study protocol
- Planned continued use of dietary supplements through the study trial
- Smoking or tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.
Read the detailed description
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.
- Conditions
- Glucose Blood, Glycemic Index
- Being tested
- High GL 107, Medium GL 76, Medium GL 68, Low GL 48
- Keywords
- glycemic Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High GL 107Other
Three meals a day
Medium GL 76Other
Three meals a day
Medium GL 68Other
Three meals a day
Low GL 48Other
Three meals a day
| Study group | Role | What they receive |
|---|---|---|
| Diet 1 | Experimental | High GI; High Carb; High GL Receives: Other: High GL 107 |
| Diet 2 | Experimental | High GI, Low Carb, Med GL Receives: Other: Medium GL 76 |
| Diet 3 | Experimental | Low GI, High Carb, Med GL Receives: Other: Medium GL 68 |
| Diet 4 | Experimental | Low GI, Low Carb, Low GL Receives: Other: Low GL 48 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose over time
Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.
Measured: 1 month
Secondary outcomes (1)
Visual Analog scores (VAS)
Hunger, satiety, and vigor will be measured by the visual analog scales.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startFeb 2007
- Primary completionJun 2007
- Study completionJun 2007
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 Glucose BloodStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L Greenway, MD, Principal investigator, Pennington Biomedical Research CenterWilliam Cefalu, MD, Study chair, Pennington Biomedial Research CenterMarlene M Most, PhD, RD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516333
- Sponsor's protocol ID
- PBRC 26026
- Status last verified
- Dec 2015
- First submitted
- 19 Jan 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11.
PubMed 22688548
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1
- ClinicalTrials.gov ID
- NCT01516333
- Acronym / sponsor ID
- PBRC 26026
- Conditions
- Glucose Blood, Glycemic Index
- Keywords
- glycemic Index
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Feb 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 24 Jan 2012 (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 study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.
Detailed description
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet 1 | Experimental | Other: High GL 107High GI; High Carb; High GL |
| Diet 2 | Experimental | Other: Medium GL 76High GI, Low Carb, Med GL |
| Diet 3 | Experimental | Other: Medium GL 68Low GI, High Carb, Med GL |
| Diet 4 | Experimental | Other: Low GL 48Low GI, Low Carb, Low GL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Body Mass index between 25-35 kg/m2
- Fasting serum glucose
- Fasting serum glucose < 125 mg/dl
- Free of chronic disease
- Willing to eat only the foods that are provided by the Center during the diet periods
Key exclusion criteria (11 listed)
- Documented presence of atherosclerotic disease
- Diabetes mellitus
- Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
- Body Mass Index <25 or > 35
- History of drug or alcohol abuse in the last year
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 |
|---|---|---|
| High GL 107Three meals a day | Other | Diet 1 |
| Medium GL 76Three meals a day | Other | Diet 2 |
| Medium GL 68Three meals a day | Other | Diet 3 |
| Low GL 48Three meals a day | Other | Diet 4 |
Primary outcome
Blood Glucose over time
Time frame: 1 month
Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.
1 secondary outcome
Visual Analog scores (VAS)
Time frame: 1 month
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 18 Dec 2015.
- Derived from this study: PubMed 22688548Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11.
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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.
Frank L Greenway, MD principal investigator
Pennington Biomedical Research Center
William Cefalu, MD study chair
Pennington Biomedial Research Center
Marlene M Most, PhD, RD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High GL 107, Medium GL 76 and Medium GL 68 in people with Glucose Blood and Glycemic Index, run by Pennington Biomedical Research Center 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 12 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 18 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood Glucose over time (time frame: 1 month). 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 NCT01516333, 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 18 Dec 2015; AzTrials last refreshed its copy on 27 Oct 2026.