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Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators

This study is currently recruiting participants.
Verified January 2014 by Tufts University
Sponsor:
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01610661
First received: November 7, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Dyslipidemia
Other: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Dietary Carbohydrate Type and CVD Risk Indicators

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • fasting plasma lipid profile [ Time Frame: 15-week period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose [ Time Frame: 15 week period ] [ Designated as safety issue: No ]
  • insulin [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • adipose tissue inflammatory markers [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • gut microbiome [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • High-sensitivity C-reactive protein(hsCRP) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • Interleukin 6 (IL-6) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • Monocyte Chemoattractant Protein 1 (MCP-1) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • Tumor necrosis factor-alpha (TNF-alpha) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
  • Monocyte gene expression [ Time Frame: 15-week period ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610661

Contacts
Contact: Alice H. Lichtenstein, D.Sc. (617) 556-3127 alice.lichtenstein@tufts.edu
Contact: Nirupa R. Matthan, Ph.D. (617) 556-3114 nirupa.matthan@tufts.edu

Locations
United States, Massachusetts
Jean Mayer Human Nutrition Research Center on Aging Recruiting
Boston, Massachusetts, United States, 02111
Contact: Volunteer Services    800-738-7555    volunteers-hrnc@tufts.edu   
Principal Investigator: Alice H. Lichtenstein, D. Sc.         
Sub-Investigator: Stefania Lamon-Flava, M.D., Ph.D.         
Sub-Investigator: Nirupa Matthan, Ph.D.         
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Alice H. Lichtenstein, D.Sc. Tufts University
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01610661     History of Changes
Other Study ID Numbers: 2735
Study First Received: November 7, 2011
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
carbohydrate
inflammation
glucose homeostasis
gene expression

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014