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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unrefined-carbohydrate | Other | unrefined carbohydrate diet |
|
| Refined-carbohydrate | Other | refined carbohydrate diet |
|
| Simple-carbohydrate | Other | simple carbohydrate diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| fasting plasma lipid profile | 15-week period |
| Measure | Description | Time Frame |
|---|---|---|
| glucose | 15 week period | |
| insulin | 15-week period | |
| adipose tissue inflammatory markers |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Alice H. Lichtenstein, D.Sc. | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer Human Nutrition Research Center on Aging | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32936872 | Derived | Faits T, Walker ME, Rodriguez-Morato J, Meng H, Gervis JE, Galluccio JM, Lichtenstein AH, Johnson WE, Matthan NR. Exploring changes in the human gut microbiota and microbial-derived metabolites in response to diets enriched in simple, refined, or unrefined carbohydrate-containing foods: a post hoc analysis of a randomized clinical trial. Am J Clin Nutr. 2020 Dec 10;112(6):1631-1641. doi: 10.1093/ajcn/nqaa254. | |
| 29982704 |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| 15-week period |
| gut microbiome | 15-week period |
| High-sensitivity C-reactive protein(hsCRP) | 15-week period |
| Interleukin 6 (IL-6) | 15-week period |
| Monocyte Chemoattractant Protein 1 (MCP-1) | 15-week period |
| Tumor necrosis factor-alpha (TNF-alpha) | 15-week period |
| Monocyte gene expression | 15-week period |
| Derived |
| Meng H, Matthan NR, Fried SK, Berciano S, Walker ME, Galluccio JM, Lichtenstein AH. Effect of Dietary Carbohydrate Type on Serum Cardiometabolic Risk Indicators and Adipose Tissue Inflammatory Markers. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3430-3438. doi: 10.1210/jc.2018-00667. |
| D013568 | Pathological Conditions, Signs and Symptoms |