Glycemic Index - Variability Among Individuals

NCT01023646 | Completed

• 1 other identifier: R01DK073321
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Obesity; Metabolic Syndrome; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glucose, Insulin, Free Fatty Acids.

  5 hours

Secondary Outcomes (1)

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

  5 hours

Study Arms (4)

carbohydrate load

OTHER

Food challenge - Carbohydrate load

Other: Carbohydrate load

Carbohydrate + Protein

OTHER

Food challenge - carbohydrate + protein

Other: Carbohydrate + Protein

Carbohydrate + Fat

OTHER

Food challenge - carbohydrate + fat

Other: Carbohydrate + Fat

Fiber

OTHER

Food challenge - carbohydrate + fiber

Other: Fiber

Interventions

Carbohydrate + Protein OTHER

Light Tuna Packed in water.

Carbohydrate + Protein

Carbohydrate + Fat OTHER

Butter

Carbohydrate + Fat

Fiber OTHER

Unrefined Carbohydrate

Fiber

Carbohydrate load OTHER

Carbohydrate

carbohydrate load

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (16)

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

  PMID: 11368702 BACKGROUND

• Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.

  PMID: 6259925 BACKGROUND

• Salmeron J, Manson JE, Stampfer MJ, Colditz GA, Wing AL, Willett WC. Dietary fiber, glycemic load, and risk of non-insulin-dependent diabetes mellitus in women. JAMA. 1997 Feb 12;277(6):472-7. doi: 10.1001/jama.1997.03540300040031.

  PMID: 9020271 BACKGROUND

• Salmeron J, Ascherio A, Rimm EB, Colditz GA, Spiegelman D, Jenkins DJ, Stampfer MJ, Wing AL, Willett WC. Dietary fiber, glycemic load, and risk of NIDDM in men. Diabetes Care. 1997 Apr;20(4):545-50. doi: 10.2337/diacare.20.4.545.

  PMID: 9096978 BACKGROUND

• Amano Y, Kawakubo K, Lee JS, Tang AC, Sugiyama M, Mori K. Correlation between dietary glycemic index and cardiovascular disease risk factors among Japanese women. Eur J Clin Nutr. 2004 Nov;58(11):1472-8. doi: 10.1038/sj.ejcn.1601992.

  PMID: 15127092 BACKGROUND

• Schulze MB, Liu S, Rimm EB, Manson JE, Willett WC, Hu FB. Glycemic index, glycemic load, and dietary fiber intake and incidence of type 2 diabetes in younger and middle-aged women. Am J Clin Nutr. 2004 Aug;80(2):348-56. doi: 10.1093/ajcn/80.2.348.

  PMID: 15277155 BACKGROUND

• Wolever TM, Csima A, Jenkins DJ, Wong GS, Josse RG. The glycemic index: variation between subjects and predictive difference. J Am Coll Nutr. 1989 Jun;8(3):235-47. doi: 10.1080/07315724.1989.10720298.

  PMID: 2760355 BACKGROUND

• Wolever TM, Jenkins DJ, Josse RG, Wong GS, Lee R. The glycemic index: similarity of values derived in insulin-dependent and non-insulin-dependent diabetic patients. J Am Coll Nutr. 1987 Aug;6(4):295-305. doi: 10.1080/07315724.1987.10720191.

  PMID: 3611527 BACKGROUND

• Jenkins DJ, Wolever TM, Wong GS, Kenshole A, Josse RG, Thompson LU, Lam KY. Glycemic responses to foods: possible differences between insulin-dependent and noninsulin-dependent diabetics. Am J Clin Nutr. 1984 Nov;40(5):971-81. doi: 10.1093/ajcn/40.5.971.

  PMID: 6496392 BACKGROUND

• Foster-Powell K, Holt SH, Brand-Miller JC. International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul;76(1):5-56. doi: 10.1093/ajcn/76.1.5.

  PMID: 12081815 BACKGROUND

• Wolever TM, Vorster HH, Bjorck I, Brand-Miller J, Brighenti F, Mann JI, Ramdath DD, Granfeldt Y, Holt S, Perry TL, Venter C, Xiaomei Wu. Determination of the glycaemic index of foods: interlaboratory study. Eur J Clin Nutr. 2003 Mar;57(3):475-82. doi: 10.1038/sj.ejcn.1601551.

  PMID: 12627186 BACKGROUND

• Wolever TM, Jenkins DJ. The use of the glycemic index in predicting the blood glucose response to mixed meals. Am J Clin Nutr. 1986 Jan;43(1):167-72. doi: 10.1093/ajcn/43.1.167.

  PMID: 3942088 BACKGROUND

• Vega-Lopez S, Ausman LM, Griffith JL, Lichtenstein AH. Interindividual variability and intra-individual reproducibility of glycemic index values for commercial white bread. Diabetes Care. 2007 Jun;30(6):1412-7. doi: 10.2337/dc06-1598. Epub 2007 Mar 23.

  PMID: 17384339 BACKGROUND

• Meng H, Matthan NR, Ausman LM, Lichtenstein AH. Effect of prior meal macronutrient composition on postprandial glycemic responses and glycemic index and glycemic load value determinations. Am J Clin Nutr. 2017 Nov;106(5):1246-1256. doi: 10.3945/ajcn.117.162727. Epub 2017 Sep 13.

  PMID: 28903959 DERIVED

• Meng H, Matthan NR, Ausman LM, Lichtenstein AH. Effect of macronutrients and fiber on postprandial glycemic responses and meal glycemic index and glycemic load value determinations. Am J Clin Nutr. 2017 Apr;105(4):842-853. doi: 10.3945/ajcn.116.144162. Epub 2017 Feb 15.

  PMID: 28202475 DERIVED

• Matthan NR, Ausman LM, Meng H, Tighiouart H, Lichtenstein AH. Estimating the reliability of glycemic index values and potential sources of methodological and biological variability. Am J Clin Nutr. 2016 Oct;104(4):1004-1013. doi: 10.3945/ajcn.116.137208. Epub 2016 Sep 7.

  PMID: 27604773 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Metabolic Syndrome; Cardiovascular Diseases; Insulin Resistance

Interventions

Carbohydrates; Proteins; CD36 Antigens; Dietary Fiber

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein; Dietary Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alice H Lichtenstein, D.Sc.

  JM USDA Human Nutrition Research Center on Aging at Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2007
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)