OverweightPhase 1NCT00622960
Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
A Phase 1 study testing High-MUFA diet and High-CHO diet in people with Overweight and Obesity, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Overweight, Obesity, Type 2 Diabetes
- What is being tested?
- High-MUFA diet and High-CHO diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of 27-40 kg/m2
- 30-75 years of age
- Stable body weight for the preceding 6 months
- Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
- HbA1c of 6.5 to 9.0
- Treatment by diet or oral agents only
Who cannot join
- Pregnancy or lactation
- Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
- Untreated thyroid disease or hypertension
- Hypertriglyceridemia with levels of TG > 500 mg/dl
- Use of insulin
- Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
- Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.
Read the detailed description
The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Being tested
- High-MUFA diet, High-CHO diet
- Keywords
- obesity, type 2 diabetes, weight loss, monounsaturated fat, diet
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-MUFA dietOther
The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
High-CHO dietOther
The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| High MUFA diet | Experimental | Those subjects assigned to a high monounsaturated fat diet Receives: Other: High-MUFA diet |
| High CHO diet | Active comparator | Those subjects assigned to a high carbohydrate diet Receives: Other: High-CHO diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: prior to and after 4, 8, and 12 months of dieting
Secondary outcomes (4)
body fat
Measured: prior to and after 4, 8, and 12 months of dieting
blood pressure
Measured: prior to and after 4, 8, and 12 months of dieting
blood lipid profile
Measured: prior to and after 4, 8, and 12 months of dieting
glycemic control (glucose, insulin, and HbA1c)
Measured: prior to and after 4, 8, and 12 months of dieting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionApr 2007
- Study completionApr 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 OverweightStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- Bonnie J Brehm, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622960
- Sponsor's protocol ID
- ADA 1-04-CR-05
- Status last verified
- Feb 2008
- First submitted
- 13 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, D'Alessio DA. One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care. 2009 Feb;32(2):215-20. doi: 10.2337/dc08-0687. Epub 2008 Oct 28.
PubMed 18957534
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00622960
- Acronym / sponsor ID
- ADA 1-04-CR-05
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Keywords
- obesity, type 2 diabetes, weight loss, monounsaturated fat, diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Feb 2008 (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 purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.
Detailed description
The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High MUFA diet | Experimental | Other: High-MUFA dietThose subjects assigned to a high monounsaturated fat diet |
| High CHO diet | Active comparator | Other: High-CHO dietThose subjects assigned to a high carbohydrate diet |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI of 27-40 kg/m2
- 30-75 years of age
- Stable body weight for the preceding 6 months
- Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
- HbA1c of 6.5 to 9.0
Key exclusion criteria (7 listed)
- Pregnancy or lactation
- Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
- Untreated thyroid disease or hypertension
- Hypertriglyceridemia with levels of TG > 500 mg/dl
- Use of insulin
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-MUFA dietThe effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control. | Other | High MUFA diet |
| High-CHO dietThe effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control. | Other | High CHO diet |
Primary outcome
body weight
Time frame: prior to and after 4, 8, and 12 months of dieting
4 secondary outcomes
body fat
Time frame: prior to and after 4, 8, and 12 months of dieting
blood pressure
Time frame: prior to and after 4, 8, and 12 months of dieting
blood lipid profile
Time frame: prior to and after 4, 8, and 12 months of dieting
glycemic control (glucose, insulin, and HbA1c)
Time frame: prior to and after 4, 8, and 12 months of dieting
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 Feb 2008.
- Derived from this study: PubMed 18957534Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, D'Alessio DA. One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care. 2009 Feb;32(2):215-20. doi: 10.2337/dc08-0687. Epub 2008 Oct 28.
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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.
Bonnie J Brehm, PhD principal investigator
University of Cincinnati
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-MUFA diet and High-CHO diet in people with Overweight and Obesity, run by University of Cincinnati 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 6 inclusion and 7 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 Feb 2008. 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?
body weight (time frame: prior to and after 4, 8, and 12 months of dieting). 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 NCT00622960, 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 25 Feb 2008.