Glycemic Index - Variability Among Individuals
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01023646 |
Recruitment Status :
Completed
First Posted : December 2, 2009
Last Update Posted : April 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Obesity Metabolic Syndrome Cardiovascular Disease | Other: Carbohydrate + Protein Other: Carbohydrate + Fat Other: Fiber Other: Carbohydrate load | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 124 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of Glycemic Index to Assess Diet Associated Chronic Disease Risk |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
carbohydrate load
Food challenge - Carbohydrate load
|
Other: Carbohydrate load
Carbohydrate |
Carbohydrate + Protein
Food challenge - carbohydrate + protein
|
Other: Carbohydrate + Protein
Light Tuna Packed in water. |
Carbohydrate + Fat
Food challenge - carbohydrate + fat
|
Other: Carbohydrate + Fat
Butter |
Fiber
Food challenge - carbohydrate + fiber
|
Other: Fiber
Unrefined Carbohydrate |
- Glucose, Insulin, Free Fatty Acids. [ Time Frame: 5 hours ]
- Fasting and non-fasting plasma lipids and lipoproteins, C reactive protein (CRP), HbAIc. [ Time Frame: 5 hours ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- For Phase 1 (Study 1) a total of seventy five volunteers will be included in the study. This study will be conducted in adult men and women (18-85 y) free of known chronic disease with BMI 18 to 35 kg/m2.
- For Phase 2 (Studies 2, 3, 4, and 5) a total of 80 volunteers will be included, 20 volunteers per study. Phase 2 studies will be conducted in adult men and women (50 - 85 y) free of known chronic disease and with a BMI of 25 to 35 kg/m2.
- For Phase 3 (Study 6) a total of 20 volunteers will be included in the study. Phase 3 study will be conducted in adult men and women (50-85 y) free of known chronic disease and with a BMI of 25 to 35 kg/m2.
Exclusion criteria:
- BMI ≥ 35 kg/m2 for Phase I, and BMI ≤ 25 to ≥ 35 kg/m2 for Phase II and III
- Renal 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 glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate 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.
- Untreated hypertension, defined as systolic blood pressure (SBP) > 140 mm and diastolic blood pressure (DBP) > 90 mm.
- Irritable bowel syndrome.
- Malabsorptive disorder and inflammatory bowel disease.
- Disorders of esophageal and gastrointestinal motility, and previous esophageal or gastric resection.
- History of chronic pancreatitis, or history of acute pancreatitis within the last year.
- Hypothyroidism or hyperthyroidism, as defined as screening thyroid-stimulating hormone (TSH) outside of normal ranges.
- Anemia, as defined by screening hematocrit of 34% for women and 38% for men.
- Smoking within the past 6 months.
- Diabetes.
- Fasting glucose ≥ 125 mg/dL.
- Pregnancy.
- Breastfeeding.
- History of polycystic ovary syndrome
- History of autoimmune or other connective tissue disorders associated with chronic inflammation, such as rheumatoid arthritis.
- Alcohol consumption > 7 drinks/week.
- Use of medications or supplements known to affect glucose metabolism.
- Use of medications or supplements known to affect lipid metabolism.
- Established cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery. bypass graft, stenosis > 50%, peripheral arterial disease).
- Unwillingness to adhere to study protocol.
- Weight gain or loss of more than 15 lbs within 6 months prior to enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023646
United States, Massachusetts | |
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Alice H Lichtenstein, D.Sc. | JM USDA Human Nutrition Research Center on Aging at Tufts University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tufts University |
ClinicalTrials.gov Identifier: | NCT01023646 |
Other Study ID Numbers: |
R01DK073321 ( U.S. NIH Grant/Contract ) R01DK073321 ( U.S. NIH Grant/Contract ) |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | April 25, 2017 |
Last Verified: | April 2017 |
Glycemic Index Glycemic Load Glucose |
Insulin Lipoproteins Free fatty acids |
Cardiovascular Diseases Metabolic Syndrome Insulin Resistance |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |