DyslipidemiaNCT01610661
Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators
A study testing Diet in people with Dyslipidemia, run by Tufts University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- < 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Dietary Carbohydrate Type and CVD Risk Indicators
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.
- Conditions
- Dyslipidemia
- Being tested
- Diet
- Keywords
- carbohydrate, inflammation, glucose homeostasis, gene expression
- Medical subject headings
- Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called simple carb, refined carb, unrefined carb
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.
| Study group | Role | What they receive |
|---|---|---|
| Unrefined-carbohydrate | Other | unrefined carbohydrate diet Receives: Other: Diet |
| Refined-carbohydrate | Other | refined carbohydrate diet Receives: Other: Diet |
| Simple-carbohydrate | Other | simple carbohydrate diet Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma lipid profile
Measured: 15-week period
Secondary outcomes (9)
glucose
Measured: 15 week period
insulin
Measured: 15-week period
adipose tissue inflammatory markers
Measured: 15-week period
gut microbiome
Measured: 15-week period
High-sensitivity C-reactive protein(hsCRP)
Measured: 15-week period
Interleukin 6 (IL-6)
Measured: 15-week period
Monocyte Chemoattractant Protein 1 (MCP-1)
Measured: 15-week period
Tumor necrosis factor-alpha (TNF-alpha)
Measured: 15-week period
Monocyte gene expression
Measured: 15-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice H. Lichtenstein, D.Sc., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610661
- Sponsor's protocol ID
- 2735
- Status last verified
- Jul 2018
- First submitted
- 7 Nov 2011
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
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 32936872Meng 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Carbohydrate Type and CVD Risk Indicators
- ClinicalTrials.gov ID
- NCT01610661
- Acronym / sponsor ID
- 2735
- Conditions
- Dyslipidemia
- Keywords
- carbohydrate, inflammation, glucose homeostasis, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unrefined-carbohydrate | Other | Other: Dietunrefined carbohydrate diet |
| Refined-carbohydrate | Other | Other: Dietrefined carbohydrate diet |
| Simple-carbohydrate | Other | Other: Dietsimple carbohydrate diet |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (31 listed)
- < 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAlso: simple carb, refined carb, unrefined carbUnrefined-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. | Other | Refined-carbohydrate, Simple-carbohydrate, Unrefined-carbohydrate |
Primary outcome
fasting plasma lipid profile
Time frame: 15-week period
9 secondary outcomes
glucose
Time frame: 15 week period
insulin
Time frame: 15-week period
adipose tissue inflammatory markers
Time frame: 15-week period
gut microbiome
Time frame: 15-week period
High-sensitivity C-reactive protein(hsCRP)
Time frame: 15-week period
Interleukin 6 (IL-6)
Time frame: 15-week period
Monocyte Chemoattractant Protein 1 (MCP-1)
Time frame: 15-week period
Tumor necrosis factor-alpha (TNF-alpha)
Time frame: 15-week period
Monocyte gene expression
Time frame: 15-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Derived from this study: PubMed 32936872Faits 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.
- Derived from this study: PubMed 29982704Meng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice H. Lichtenstein, D.Sc. principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Dyslipidemia, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting plasma lipid profile (time frame: 15-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01610661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.