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Glycemic Index - Variability Among Individuals

Primary Purpose

Diabetes, Obesity, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Carbohydrate + Protein

Carbohydrate + Fat

Fiber

Carbohydrate load

About this trial

This is an interventional basic science trial for Diabetes focused on measuring Glycemic Index, Glycemic Load, Glucose, Insulin, Lipoproteins, Free fatty acids

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

carbohydrate load

Carbohydrate + Protein

Carbohydrate + Fat

Fiber

Arm Description

Food challenge - Carbohydrate load

Food challenge - carbohydrate + protein

Food challenge - carbohydrate + fat

Food challenge - carbohydrate + fiber

Outcomes

Primary Outcome Measures

Glucose, Insulin, Free Fatty Acids.

Secondary Outcome Measures

Fasting and non-fasting plasma lipids and lipoproteins, C reactive protein (CRP), HbAIc.

Full Information

NCT ID

NCT01023646

First Posted

November 30, 2009

Last Updated

April 24, 2017

Sponsor

Tufts University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01023646

Brief Title

Glycemic Index - Variability Among Individuals

Official Title

Evaluation of Glycemic Index to Assess Diet Associated Chronic Disease Risk

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Obesity, Metabolic Syndrome, Cardiovascular Disease

Keywords

Glycemic Index, Glycemic Load, Glucose, Insulin, Lipoproteins, Free fatty acids

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

carbohydrate load

Arm Type

Other

Arm Description

Food challenge - Carbohydrate load

Arm Title

Carbohydrate + Protein

Arm Type

Other

Arm Description

Food challenge - carbohydrate + protein

Arm Title

Carbohydrate + Fat

Arm Type

Other

Arm Description

Food challenge - carbohydrate + fat

Arm Title

Fiber

Arm Type

Other

Arm Description

Food challenge - carbohydrate + fiber

Intervention Type

Other

Intervention Name(s)

Carbohydrate + Protein

Intervention Description

Light Tuna Packed in water.

Intervention Type

Other

Intervention Name(s)

Carbohydrate + Fat

Intervention Description

Butter

Intervention Type

Other

Intervention Name(s)

Fiber

Intervention Description

Unrefined Carbohydrate

Intervention Type

Other

Intervention Name(s)

Carbohydrate load

Intervention Description

Carbohydrate

Primary Outcome Measure Information:

Title

Glucose, Insulin, Free Fatty Acids.

Time Frame

5 hours

Secondary Outcome Measure Information:

Title

Fasting and non-fasting plasma lipids and lipoproteins, C reactive protein (CRP), HbAIc.

Time Frame

5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice H Lichtenstein, D.Sc.

Organizational Affiliation

JM USDA Human Nutrition Research Center on Aging at Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

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