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CompletedNCT01610661Updated Jul 13, 2018

Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators

An interventional study of Diet in Dyslipidemia, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Tufts University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • carbohydrate
  • inflammation
  • glucose homeostasis
  • gene expression
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's planned enrollment of 10 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Unrefined-carbohydrate

    unrefined carbohydrate diet

    Other: Diet

  • Other
    Refined-carbohydrate

    refined carbohydrate diet

    Other: Diet

  • Other
    Simple-carbohydrate

    simple carbohydrate diet

    Other: Diet

Interventions

  • OtherDiet

    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

06

What researchers measure

Primary outcomes

  1. fasting plasma lipid profile

    Time frame: 15-week period

Secondary outcomes

  1. glucose

    Time frame: 15 week period

  2. insulin

    Time frame: 15-week period

  3. adipose tissue inflammatory markers

    Time frame: 15-week period

  4. gut microbiome

    Time frame: 15-week period

  5. High-sensitivity C-reactive protein(hsCRP)

    Time frame: 15-week period

  6. Interleukin 6 (IL-6)

    Time frame: 15-week period

  7. Monocyte Chemoattractant Protein 1 (MCP-1)

    Time frame: 15-week period

  8. Tumor necrosis factor-alpha (TNF-alpha)

    Time frame: 15-week period

  9. Monocyte gene expression

    Time frame: 15-week period

07

Study locations

1 site
  • Jean Mayer Human Nutrition Research Center on Aging
    Boston, Massachusetts 02111, United States
08

References and documents

Publications

  • 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. PubMed 32936872 ↗
  • 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. PubMed 29982704 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01610661
Lead sponsor
Tufts University
Responsible party
Sponsor
First posted
Jun 4, 2012
Start date
Jan 2012
Primary completion
Apr 2015
Completion
Dec 2017
Last update
Jul 13, 2018

Study contacts

Alice H. Lichtenstein, D.Sc.
principal investigator · Tufts University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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