Insulin ResistanceNCT00508937
Dietary Protein and Insulin Sensitivity Study
A study testing Diet in people with Insulin Resistance and Type 2 Diabetes, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.
Trial summary
The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Dec 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
- HOMA-IR ≥ 2.5
- Non-smoking
- Total cholesterol and LDL cholesterol <95th percentile for sex and age
- Fasting triglycerides < 500mg/dl
- Fasting blood sugar < 126
Show all 11Show fewer
- Urinary microalbumin < 30 mg/L
- Normal thyroid stimulating hormone levels
- Hematocrit ≥ 36%
- Blood pressure < 150/90
- At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase
Who cannot join
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
- Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
- Use of alcohol or dietary supplements during the study
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cholesterol Research Center
Berkeley, California, 94705
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: The Effects of Increased Dietary Protein Intake on Insulin Sensitivity in Stable Weight Individuals, Independent of Dietary Content of Carbohydrate and Saturated Fat
The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.
Read the detailed description
Insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. The effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. To better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. At the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIGT) method. In addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.
- Conditions
- Insulin Resistance, Type 2 Diabetes, Metabolic Syndrome, Cardiovascular Disease, Dyslipidemia
- Being tested
- Diet
- Keywords
- Diet, Protein, Glucose, Insulin, Cholesterol, Triglycerides, LDL subclasses
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Metabolic Syndrome, Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
DietOther
20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
DietOther
20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
DietOther
30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
DietOther
30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: Diet |
| 2 | Experimental | Not described Receives: Other: Diet |
| 3 | Experimental | Not described Receives: Other: Diet |
| 4 | Experimental | Not described Receives: Other: Diet |
| 5 | Experimental | Not described Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test
Measured: 4wks and 8wks
Total Cholesterol
Measured: 4wks and 8wks
LDL Cholesterol
Measured: 4wks and 8wks
HDL Cholesterol
Measured: 4wks and 8wks
Triglycerides
Measured: 4wks and 8wks
LDL peak particle size
Measured: 4wks and 8wks
LDL subclasses
Measured: 4wks and 8wks
Secondary outcomes (2)
Apolipoprotein B
Measured: 4wks and 8wks
Apolipoprotein A1
Measured: 4wks and 8wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009
- Study completionDec 2009
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 Insulin ResistanceStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, M.D., Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508937
- Sponsor's protocol ID
- MM3717
- Status last verified
- Dec 2020
- First submitted
- 26 Jul 2007
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiu S, Williams PT, Dawson T, Bergman RN, Stefanovski D, Watkins SM, Krauss RM. Diets high in protein or saturated fat do not affect insulin sensitivity or plasma concentrations of lipids and lipoproteins in overweight and obese adults. J Nutr. 2014 Nov;144(11):1753-9. doi: 10.3945/jn.114.197624. Epub 2014 Sep 3.
PubMed 25332473
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Increased Dietary Protein Intake on Insulin Sensitivity in Stable Weight Individuals, Independent of Dietary Content of Carbohydrate and Saturated Fat
- ClinicalTrials.gov ID
- NCT00508937
- Acronym / sponsor ID
- MM3717
- Conditions
- Insulin Resistance, Type 2 Diabetes, Metabolic Syndrome, Cardiovascular Disease, Dyslipidemia
- Keywords
- Diet, Protein, Glucose, Insulin, Cholesterol, Triglycerides, LDL subclasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Jul 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.
The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.
Detailed description
Insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. The effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. To better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. At the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIGT) method. In addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Diet |
| 2 | Experimental | Other: Diet |
| 3 | Experimental | Other: Diet |
| 4 | Experimental | Other: Diet |
| 5 | Experimental | Other: Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
- HOMA-IR ≥ 2.5
- Non-smoking
- Total cholesterol and LDL cholesterol <95th percentile for sex and age
- Fasting triglycerides < 500mg/dl
Key exclusion criteria (4 listed)
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
- Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
- Use of alcohol or dietary supplements during the study
- Pregnancy
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 |
|---|---|---|
| Diet15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated) | Other | 1 |
| Diet20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated) | Other | 2 |
| Diet20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated) | Other | 3 |
| Diet30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated) | Other | 4 |
| Diet30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated) | Other | 5 |
Primary outcome
Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test
Time frame: 4wks and 8wks
Total Cholesterol
Time frame: 4wks and 8wks
LDL Cholesterol
Time frame: 4wks and 8wks
HDL Cholesterol
Time frame: 4wks and 8wks
Triglycerides
Time frame: 4wks and 8wks
LDL peak particle size
Time frame: 4wks and 8wks
LDL subclasses
Time frame: 4wks and 8wks
2 secondary outcomes
Apolipoprotein B
Time frame: 4wks and 8wks
Apolipoprotein A1
Time frame: 4wks and 8wks
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 23 Dec 2020.
- Derived from this study: PubMed 25332473Chiu S, Williams PT, Dawson T, Bergman RN, Stefanovski D, Watkins SM, Krauss RM. Diets high in protein or saturated fat do not affect insulin sensitivity or plasma concentrations of lipids and lipoproteins in overweight and obese adults. J Nutr. 2014 Nov;144(11):1753-9. doi: 10.3945/jn.114.197624. Epub 2014 Sep 3.
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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.
Ronald M Krauss, M.D. principal investigator
UCSF Benioff Children's Hospital Oakland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Insulin Resistance and Type 2 Diabetes, run by UCSF Benioff Children's Hospital Oakland at 2 sites 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 11 inclusion and 4 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 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test (time frame: 4wks and 8wks). The study lists 7 primary outcomes in all. 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 NCT00508937, 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 23 Dec 2020.