Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators

Dyslipidemia Clinical Trial

Official title:

Dietary Carbohydrate Type and CVD Risk Indicators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610661
• Other study ID #: 2735
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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.

Locations

Country	Name	City	State
United States	Jean Mayer Human Nutrition Research Center on Aging	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting plasma lipid profile		15-week period
Secondary	glucose		15 week period
Secondary	insulin		15-week period
Secondary	adipose tissue inflammatory markers		15-week period
Secondary	gut microbiome		15-week period
Secondary	High-sensitivity C-reactive protein(hsCRP)		15-week period
Secondary	Interleukin 6 (IL-6)		15-week period
Secondary	Monocyte Chemoattractant Protein 1 (MCP-1)		15-week period
Secondary	Tumor necrosis factor-alpha (TNF-alpha)		15-week period
Secondary	Monocyte gene expression		15-week period