Cardiovascular DiseasesNCT02379897
Diet, Obesity and Cardiovascular Risk Study
A study testing Diet in people with Cardiovascular Diseases and Obesity, run by Tufts University.
Trial summary
Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Obesity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jan 2004
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 28-28 kg/m2
- Male or postmenopausal female 45-65 yr
Who cannot join
- Abnormal thyroid, liver, kidney function
- Abnormal hemoglobin
- LDL-cholesterol ≤ 100 mg/dL
- Fasting triglycerides ≥ 400 mg/dL
- Diabetes or on medication for diabetes
- Chronic illness
- Elevated blood lipids
About this study
Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks, then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.
- Conditions
- Cardiovascular Diseases, Obesity
- Being tested
- Diet
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
| Study group | Role | What they receive |
|---|---|---|
| LowGI+ModCarb | Experimental | Low glycemic index + moderate carbohydrate/moderate fat diet Receives: Other: Diet |
| LowGI+HighCarb | Experimental | Low glycemic index + high carbohydrate/low fat diet Receives: Other: Diet |
| HighGI+ModCarb | Experimental | High glycemic index + moderate carbohydrate/moderate fat diet Receives: Other: Diet |
| HighGI+HighCarb | Experimental | High glycemic index + high carbohydrate/low fat diet Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline to 12 weeks
Secondary outcomes (13)
Change in fasting plasma high density lipoprotein cholesterol
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma low density lipoprotein cholesterol-cholesterol
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma very low density lipoprotein cholesterol-cholesterol
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma triglycerides
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma insulin
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting blood glucose
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in glycated hemoglobin
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in plasma C-reactive protein
Measured: Baseline to 12 weeks, 17 weeks, and 16 months
Change in body fat
Measured: Baseline to 12 weeks and 17 weeks
Change in resting metabolic rate
Measured: Baseline to 12 weeks and 17 weeks
Change in blood pressure
Measured: Baseline to 12weeks, 17weeks and 16months
Change in body weight
Measured: Baseline to 17weeks and 16months
Change in postprandial blood glucose
Oral glucose tolerance test
Measured: Baseline to 12weeks and 17weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2000
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Roberts, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379897
- Sponsor's protocol ID
- R01HL 57981
- Status last verified
- Feb 2015
- First submitted
- 14 Feb 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Obesity and Cardiovascular Risk Study
- ClinicalTrials.gov ID
- NCT02379897
- Acronym / sponsor ID
- R01HL 57981
- Conditions
- Cardiovascular Diseases, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Sep 2000
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 5 Mar 2015 (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.
Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks, then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LowGI+ModCarb | Experimental | Other: DietLow glycemic index + moderate carbohydrate/moderate fat diet |
| LowGI+HighCarb | Experimental | Other: DietLow glycemic index + high carbohydrate/low fat diet |
| HighGI+ModCarb | Experimental | Other: DietHigh glycemic index + moderate carbohydrate/moderate fat diet |
| HighGI+HighCarb | Experimental | Other: DietHigh glycemic index + high carbohydrate/low fat diet |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 28-28 kg/m2
- Male or postmenopausal female 45-65 yr
Key exclusion criteria (7 listed)
- Abnormal thyroid, liver, kidney function
- Abnormal hemoglobin
- LDL-cholesterol ≤ 100 mg/dL
- Fasting triglycerides ≥ 400 mg/dL
- Diabetes or on medication for diabetes
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 |
|---|---|---|
| Diet | Other | HighGI+HighCarb, HighGI+ModCarb, LowGI+HighCarb, LowGI+ModCarb |
Primary outcome
Change in body weight
Time frame: Baseline to 12 weeks
13 secondary outcomes
Change in fasting plasma high density lipoprotein cholesterol
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma low density lipoprotein cholesterol-cholesterol
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma very low density lipoprotein cholesterol-cholesterol
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma triglycerides
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma insulin
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting blood glucose
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in glycated hemoglobin
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in plasma C-reactive protein
Time frame: Baseline to 12 weeks, 17 weeks, and 16 months
Change in body fat
Time frame: Baseline to 12 weeks and 17 weeks
Change in resting metabolic rate
Time frame: Baseline to 12 weeks and 17 weeks
Change in blood pressure
Time frame: Baseline to 12weeks, 17weeks and 16months
Change in body weight
Time frame: Baseline to 17weeks and 16months
Change in postprandial blood glucose
Time frame: Baseline to 12weeks and 17weeks
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 5 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Cardiovascular Diseases and Obesity, run by Tufts University.
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 2 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in body weight (time frame: Baseline to 12 weeks). 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 5 Mar 2015.