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Dietary Carbohydrate Type and CVD Risk Indicators

50 Years
85 Years
Open (Enrolling)

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Trial Information

Dietary Carbohydrate Type and CVD Risk Indicators

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.

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

- 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

- Use of hormone therapy medications containing estrogen

- Use of fish oil/omega-3 supplements, and Metamucil (or fiber containing dietary

- Any Aspirin, non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use or
therapies that cannot be discontinued by subject for 72 hours prior to and 72 hours
after fat biopsy procedure.

- Established cardiovascular disease as defined by history of myocardial infarction,
stroke, heart failure, coronary artery bypass graft, stenosis > 50%, angina and
peripheral arterial disease

- Untreated hypertension, defined as systolic blood pressure (SBP) > 140 mm and
diastolic blood pressure (DBP) > 90 mm

- 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

- 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 thyroid stimulating hormone
(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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

fasting plasma lipid profile

Outcome Time Frame:

15-week period

Safety Issue:


Principal Investigator

Alice H. Lichtenstein, D.Sc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts University


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

September 2014

Related Keywords:

  • Dyslipidemia
  • carbohydrate
  • inflammation
  • glucose homeostasis
  • gene expression
  • Cardiovascular Diseases
  • Dyslipidemias



Jean Mayer Human Nutrition Research Center on AgingBoston, Massachusetts  02111