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Study of Macronutrients and Heart Disease Risk (MACRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lydia A. Bazzano, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00609271
First received: January 24, 2008
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults.

The investigators will test the following hypotheses:

Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.


Condition Intervention
Obesity
Body Composition
Blood Pressure
Cardiovascular Diseases
Behavioral: low carbohydrate
Behavioral: TLC diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Macronutrient Composition of Diet and Risk Factors for Cardiovascular Disease

Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
low carbohydrate diet
Behavioral: low carbohydrate
<40 grams carbohydrate/day
Active Comparator: 2
therapeutic lifestyle change diet
Behavioral: TLC diet
<35% fat, <7% saturated fat

Detailed Description:

Cardiovascular diseases (CVD) remain the leading cause of death globally as well as here in the United States. Manipulations of the macronutrient (protein, carbohydrate and fat) contents of diet have been used extensively for weight loss and weight control in the past several decades. Low carbohydrate diets, in particular, have gained popularity for weight loss. However, few studies have examined the effects of a diet low in carbohydrates on traditional and novel cardiovascular risk factors in the long term, particularly in contrast to the current dietary recommendations for decreased fat intake to reduce risk of CVD. In this proposal, we plan to conduct a 12-month, parallel-arm, randomized controlled trial of a diet low in carbohydrates versus the currently recommended low fat diet to reduce CVD risk factors among obese adults. The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on CVD risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults. In order to accomplish these objectives we will randomize 130 eligible participants (n=65 in each group) to consume either a diet low in carbohydrates (≤40 g/d) or a diet low in fat (<7% saturated fat, <35% total fat). Neither of the diets will be energy-restricted. Participants will meet with a dietitian for one-on-one counseling sessions weekly for the first 4 weeks, then bi-monthly in small group sessions for the next 5 months, and monthly in larger group sessions for the final 6 months of the intervention. Data on both traditional and novel CVD risk factors will be collected at baseline, 3, 6, and 12 months. We hypothesize that a diet low in carbohydrates as compared to a diet low in fat will lower systolic and diastolic BP, body weight, total percent body fat, waist circumference, serum levels of triglycerides, and plasma levels of insulin, glucose, leptin, resistin, and CRP, and increase serum levels of HDL-cholesterol and adiponectin. Because CVD is the most common cause of death here in the U.S. and world-wide, this study has important public health implications. It will provide new information on the potential long-term effects of diets low in carbohydrates on both the traditional risk factors for CVD as well as novel risk factors and inflammatory factors. The results from this study will help to determine if a diet low in carbohydrates as compared to the currently recommended low fat diet can decrease the risk of CVD among obese adults.

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women aged 22 - 75 years, any race/ethnicity
  • BMI of 30 - 45 k/m2
  • Willing and able to provide informed consent

Exclusion Criteria:

  • History of self-reported clinical CVD (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
  • Medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
  • Current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
  • For women, current pregnancy or breastfeeding or plans to become pregnant during the study period
  • Consumption of more than 21 alcoholic beverages per week
  • Currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
  • Plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
  • Participation of another household member in the study; employees or persons living with employees of the study
  • Participation in other lifestyle intervention trials currently
  • At the discretion of the study coordinator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609271

Locations
United States, Louisiana
Tulane University, Office of Health Research
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Principal Investigator: Lydia A Bazzano, MD, PhD Tulane University
  More Information

Additional Information:
No publications provided by Tulane University Health Sciences Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lydia A. Bazzano, Associate Professor Epidemiology, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00609271     History of Changes
Other Study ID Numbers: 07-00111
Study First Received: January 24, 2008
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014