Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators

July 12, 2018 updated by: Tufts University

Dietary Carbohydrate Type and CVD Risk Indicators

The aim of this study is to determine the effect of habituation to diets with different types of carbohydrate (simple-carb, refined-carb, unrefined-carb) on selected Cardiovascular Disease (CVD) risk indicators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this pilot study is to determine the relative comparability for an isocaloric exchange of (1) refined-carb for simple-carb and (2) refined-carb for unrefined-carb, on established and emerging CVD risk indicators. To achieve this goal, subjects with moderate dyslipidemia (LDL cholesterol > 100mg/dL) will consume diets enriched in 3 types of carbohydrate (simple-carb, refined-carb and unrefined-carb) according to a randomized, cross-over design.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer Human Nutrition Research Center on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • LDL cholesterol (>100 mg/dL)
  • > 50 years (all females postmenopausal, as defined by complete natural cessation of menses for > 12 months or a bilateral oophorectomy)
  • BMI > 25 and < 35 kg/m2
  • Normal kidney function as assessed by serum creatinine and blood urea nitrogen
  • Normal liver function as assessed by serum glutamic oxaloacetic transaminase and alkaline phosphatase
  • Normal thyroid function as assessed by serum thyroid stimulating hormone concentrations
  • Normal gastrointestinal function
  • Fasting plasma glucose concentrations < 120 mg/dL
  • Normotensive with or without medication
  • Non-smoker for at least 12 months
  • Alcohol intake of less than 7 drinks per week
  • Consistent physical activity pattern

Exclusion Criteria:

  • < 50 years old
  • BMI < 25 and > 35 kg/m2
  • LDL cholesterol <100 mg/dL
  • Abnormal fasting plasma glucose levels >120 mg/dL

  • Use of medications known to affect lipid metabolism:

    • Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
    • Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
    • Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
    • Fibrates (Gemfibrozil [Lopid], Ciprofibrate, Fenofibrate [Tricor], etc)
    • Probucol
  • Use of anticoagulants (Coumadin, Heparin, Plavix, etc), anabolic steroids, and hydrocortisone
  • Use of hormone therapy medications containing estrogen
  • Use of fish oil / omega-3 supplements, and Metamucil (or fiber containing dietary supplements)
  • Any Aspirin, non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use or therapies that cannot be discontinued by subject for 72 hours prior to blood draws and adipose tissue collection and any NSAIDS for 72 hours after the procedure for obtaining adipose tissue sample
  • Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease
  • Uncontrolled hypertension or high blood pressure reading at the discretion of the study physician or nurse
  • Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests
  • Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of serum glutamic-pyruvic transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal
  • Hypothyroidism or hyperthyroidism, defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
  • Type I and II diabetes
  • Gastrointestinal disease
  • Lidocaine Allergy
  • Smoking within the past 12 months.
  • Alcohol intake > 7 drinks per week or unwillingness to not consume alcohol while participating in the study
  • Unwillingness to maintain body weight during participation in the study
  • Unwillingness to adhere to diet and study protocol
  • Weight gain or loss of more than 15 lb within 6 months prior to enrollment
  • Non-English speaking subjects
  • No Social Security number
  • Food allergies or aversions
  • Blood donation within the past 8 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Unrefined-carbohydrate
unrefined carbohydrate diet
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
  • simple carb
  • refined carb
  • unrefined carb
Other: Refined-carbohydrate
refined carbohydrate diet
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
  • simple carb
  • refined carb
  • unrefined carb
Other: Simple-carbohydrate
simple carbohydrate diet
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
  • simple carb
  • refined carb
  • unrefined carb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fasting plasma lipid profile
Time Frame: 15-week period
15-week period

Secondary Outcome Measures

Outcome Measure
Time Frame
glucose
Time Frame: 15 week period
15 week period
insulin
Time Frame: 15-week period
15-week period
adipose tissue inflammatory markers
Time Frame: 15-week period
15-week period
gut microbiome
Time Frame: 15-week period
15-week period
High-sensitivity C-reactive protein(hsCRP)
Time Frame: 15-week period
15-week period
Interleukin 6 (IL-6)
Time Frame: 15-week period
15-week period
Monocyte Chemoattractant Protein 1 (MCP-1)
Time Frame: 15-week period
15-week period
Tumor necrosis factor-alpha (TNF-alpha)
Time Frame: 15-week period
15-week period
Monocyte gene expression
Time Frame: 15-week period
15-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Investigators

  • Principal Investigator: Alice H. Lichtenstein, D.Sc., Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

June 1, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe