Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators

NCT01610661 | Completed

• 1 other identifier: 2735
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia

Keywords

carbohydrate; inflammation; glucose homeostasis; gene expression

Outcome Measures

Primary Outcomes (1)

• fasting plasma lipid profile

  15-week period

Secondary Outcomes (9)

• glucose

  15 week period

• insulin

  15-week period

• adipose tissue inflammatory markers

  15-week period

• gut microbiome

  15-week period

• High-sensitivity C-reactive protein(hsCRP)

  15-week period

Study Arms (3)

Unrefined-carbohydrate

OTHER

unrefined carbohydrate diet

Other: Diet

Refined-carbohydrate

OTHER

refined carbohydrate diet

Other: Diet

Simple-carbohydrate

OTHER

simple carbohydrate diet

Other: Diet

Interventions

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.

Also known as: simple carb, refined carb, unrefined carb

Refined-carbohydrate; Simple-carbohydrate; Unrefined-carbohydrate

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• 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.

  PMID: 32936872 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.

  PMID: 29982704 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Alice H. Lichtenstein, D.Sc.

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: June 4, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2017
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

US (1)