Overview

This trial is active, not recruiting.

Condition dyslipidemia
Treatment diet
Sponsor Tufts University
Start date January 2012
End date December 2015
Trial size 10 participants
Trial identifier NCT01610661, 2735

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Other)
unrefined carbohydrate diet
diet simple carb
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)
refined carbohydrate diet
diet simple carb
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)
simple carbohydrate diet
diet simple carb
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.

Primary Outcomes

Measure
fasting plasma lipid profile
time frame: 15-week period

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Dietary Carbohydrate Type and CVD Risk Indicators
Principal investigator Alice H. Lichtenstein, D.Sc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Tufts University.