| Conditions: |
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Diabetes - Obesity - Metabolic Syndrome - Cardiovascular Disease |
| Purpose: |
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The purpose of this study is to determine the variability in glycemic index determinations
for individual foods and food combinations. The study will also evaluate the changes in
insulin and free fatty acid levels, plasma lipid and lipoprotein profiles, C-reactive
protein-a marker of inflammation and glycosylated hemoglobin- a marker of glucose metabolism
during a five-hour period after eating the food or foods. Additionally, supplementary data
on variation in oral sensation, habitual food intake, food preferences and genes mediating
sensory perception and dietary behaviors (supported by a grant from the Tufts Ross Aging
Initiative) will be related to the outcomes on the present study.
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| Study Summary: |
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The objective of this proposal is to investigate the intra-individual reproducibility
(within the same individual, when repeatedly measured) and inter-individual variability
(among individuals) of glycemic index (GI) and glycemic load (GL) value determinations for
individual foods and food combinations. The specific aims to accomplished this objective
are to evaluate reproducibility and variability of GI value determinations in volunteers
differing in biologic characteristics - body mass index (BMI), age and gender; assess the
effect of macronutrient amounts and combinations, and fiber on variability of GI and GL
value determinations; assess the effect of prior meal macronutrient composition ('second
meal' effect) on GI value determinations; and relate these data to chronic disease risk
factors monitored prior to and during the intervention period. These aims will be
accomplished by assessing intra-individual reproducibility and inter-individual variability
of repeated GI value determinations for white bread, commonly used as a reference food,
relative to glucose, in volunteers selected to represent a range of BMI's (18-24.9, 25-29.9,
30-35) and ages (18-49.9, 50-85 y), and on the basis of gender, and relate these data to
body composition and insulin sensitivity (Phase I). This work will then be extended to
address issues related to variability potentially introduced by differences in macronutrient
and fiber combinations and loads (Phase II), and finally by 'second meal' effects (Phase
III). Prior to each set of food challenges (glucose and test food[s] in random order)
volunteers will be characterized on the basis of fasting HbA1c; lipids and lipoproteins;
insulin, glucose and C-reactive protein. During the 5-hour challenge (sampling at 0, 15,
30, 45, 60, and every 30 minutes thereafter) volunteers will be monitored for changes in
blood glucose, insulin, triglycerides, total, low density lipoprotein and high density
lipoprotein cholesterol, and non-esterified fatty acid levels. Additionally, supplementary
data on variation in oral sensation, habitual food intake, food preferences and genes
mediating sensory perception and dietary behaviors (supported by a grant from the Tufts Ross
Aging Initiative) will be related to the outcomes on the present study. The concepts of both
GI and GL are in the public domain and it has been suggested that the concepts be
incorporated into U.S. federal dietary guidance (U.S. Dietary Guidelines and Dietary
References Intakes [DRI]) formulated to promote health and reduce chronic disease risk.
This proposal addresses some of the understudied areas for which additional information
would be useful in order to determine whether GI and GL should be used to classify foods on
an individual basis, as has been suggested, and when formulating dietary guidance for the
general population.
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| Criteria: |
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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 SGPT or 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 SBP > 140 mm and 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 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 CVD (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.
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| NCT ID: |
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NCT01023646 |
| Primary Contact: |
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Principal Investigator
Alice H Lichtenstein, D.Sc.
JM USDA Human Nutrition Research Center on Aging at Tufts University
Alice H Lichtenstein, D.Sc.
Phone: 617/556-3127
Email: alice.lichtenstein@tufts.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02111
United States
Alice H Lichtenstein, DSc
Phone: 617-556-3127
Email: alice.lichtenstein@tufts.edu
Site Status: Recruiting |