Body Weight ChangesFructoseNCT01061346
Effect of Dietary Fat When Eaten With Fructose Versus Glucose
A study testing 40% Fat Diet, 20% Fructose Beverage and 20% Glucose Beverage in people with Body Weight Changes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy. Read more about this study
- Who is it for?
- Ages 28 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- 40% Fat Diet, 20% Fructose Beverage and 20% Glucose Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2015
- 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 28 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25 and 35 kg/m2 inclusive
- At least one of the following:
- Impaired fasting glucose between 100-125 mg/dl inclusive
- HDL below 40 mg/dl for men or below 50 mg/dl for females
- Triglycerides between 150 mg/dl and 400 mg/dl inclusive
- Blood pressure above or equal to 135 / 85 mm Hg
- Waist circumference >94cm (37 inches) for men or >80cm for women
- Mainly Healthy
Who cannot join
- Unable or unlikely to eat study foods and only foods provided by PRBC
- Taking routine medications except birth control pills
- Smoke, Abuse drugs,or Alcohol
- Pregnant or breastfeeding, irregular menstrual cycles, Post-menopausal,or PCOS
- Diabetes, heart, lung, liver, blood, or Kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennintgon Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.
Read the detailed description
After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7 day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test day, participants are randomized to one of 3 diet assignments and then test again:
1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and waist measurement.
- Conditions
- Body Weight Changes
- Being tested
- 40% Fat Diet, 20% Fructose Beverage, 20% Glucose Beverage
- Keywords
- Fructose, Glucose
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40% Fat Diet, 20% Fructose BeverageOther
Also called Fructose vs. Glucose
40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
20% Glucose BeverageOther
Also called Fructose vs. Glucose
40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
20% Glucose BeverageOther
Also called Fructose vs Glucose
20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
| Study group | Role | What they receive |
|---|---|---|
| High Fat Diet with Fructose | Experimental | 40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein Receives: Other: 40% Fat Diet, 20% Fructose Beverage |
| High Fat Diet with Glucose | Experimental | 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein Receives: Other: 20% Glucose Beverage |
| Low Fat Diet with Glucose | Experimental | 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein. Receives: Other: 20% Glucose Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, George A. Bray, Pennington Biomedical Research Center
- Investigators
- George A Bray, MD, Principal investigator, Pennington Biomedical Research CenterSudip Bajpcyi, PhD, Study chair, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061346
- Sponsor's protocol ID
- PBRC 29025
- Acronym
- Fructose
- Status last verified
- Jan 2016
- First submitted
- 1 Feb 2010
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fat When Eaten With Fructose vs. Glucose on Insulin Resistance and Liver Fat
- ClinicalTrials.gov ID
- NCT01061346
- Acronym / sponsor ID
- Fructose / PBRC 29025
- Conditions
- Body Weight Changes
- Keywords
- Fructose, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- Oct 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Feb 2010 (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 study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.
Detailed description
After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7 day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test day, participants are randomized to one of 3 diet assignments and then test again:
1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and waist measurement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Fat Diet with Fructose | Experimental | Other: 40% Fat Diet, 20% Fructose Beverage40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein |
| High Fat Diet with Glucose | Experimental | Other: 20% Glucose Beverage40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein |
| Low Fat Diet with Glucose | Experimental | Other: 20% Glucose Beverage20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein. |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI between 25 and 35 kg/m2 inclusive
- At least one of the following:
- Waist circumference >94cm (37 inches) for men or >80cm for women
- Mainly Healthy
Key exclusion criteria (5 listed)
- Unable or unlikely to eat study foods and only foods provided by PRBC
- Taking routine medications except birth control pills
- Smoke, Abuse drugs,or Alcohol
- Pregnant or breastfeeding, irregular menstrual cycles, Post-menopausal,or PCOS
- Diabetes, heart, lung, liver, blood, or Kidney disease
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 |
|---|---|---|
| 40% Fat Diet, 20% Fructose BeverageAlso: Fructose vs. Glucose40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein | Other | High Fat Diet with Fructose |
| 20% Glucose BeverageAlso: Fructose vs. Glucose40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein | Other | High Fat Diet with Glucose |
| 20% Glucose BeverageAlso: Fructose vs Glucose20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein | Other | Low Fat Diet with Glucose |
Primary outcome
Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar.
Time frame: One 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 25 Jan 2016.
Related trials for Body Weight Changes
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
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.
George A Bray, MD principal investigator
Pennington Biomedical Research Center
Sudip Bajpcyi, PhD study chair
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 study testing 40% Fat Diet, 20% Fructose Beverage and 20% Glucose Beverage in people with Body Weight Changes, 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 8 inclusion and 5 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 Jan 2016. 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 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?
Evidence to determine whether intake in beverages that provide 20% fructose or a similar beverage made with glucose given with a higher fat diet has an effect on your body weight, blood pressure, fats in your liver or your blood sugar. (time frame: One Month). 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 Jan 2016.