Glycemic Index of Commonly Consumed Sweeteners

The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Other: Glucose100; Other: Oral Glucose Tolerance Test; Other: Glucose50; Other: Glucose42

Detailed Description

This three arm study is intended to add to scientific knowledge by providing accurate assessments of the glycemic index commonly consumed food items. This will be used in the scientific literature to assess the glycemic index of foods containing various sweeteners. Participants will be monitored for a total of 10 weeks.

The glycemic index is defined as the "incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed." In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Center for Clinical Investigation Church Street Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 18.5-24.9 (lean)
• no medications
• no weight changes over the previous 6 months (defined as >=10% change in body weight)

Exclusion Criteria:

• current active participation in a weight loss program (dietary or physical activity focused)
• prior bariatric surgery
• significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes
• women who are pregnant or lactating
• medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
• no major medical or surgical event requiring hospitalization in the past 3 months
• no disease or drugs that influence digestion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucose100; Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.	Other: Glucose100; Other: Oral Glucose Tolerance Test; For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.; Other Names: OGTT
Active Comparator: Glucose50; Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.	Other: Oral Glucose Tolerance Test; For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.; Other Names: OGTT; Other: Glucose50
Active Comparator: Glucose42; Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.	Other: Oral Glucose Tolerance Test; For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.; Other Names: OGTT; Other: Glucose42

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Glycemic Index	The mean glycemic index of participants will be calculated by averaging the 3 calculated glycemic index values for each of the 3 types of sweetener. Each participant will be randomly given 1 of 3 the commonly consumed sweeteners three different times over a nine week period- for a total of 3 observations per arm. Glycemic index is measured by giving test subjects the commonly consumed sweetener, and then measuring blood glucose response over a two hour time period using an Oral Glucose Tolerance Test. That response is then compared against a reference (glucose) and averaged across all subjects to get a relative index value. The glycemic index (GI) is a ranking of carbohydrates on a scale from 0 to 100 according to the extent to which they raise blood sugar levels after eating. (http://www.glycemicindex.com/about.php)	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	BMI will be captured at the baseline visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters)	Baseline
Body Mass Index (BMI)	BMI will be captured at the 9 weeks visit, it will calculated using the formula Weight in Kilograms / ( Height in Meters x Height in Meters)	9 weeks
Percent Fat Mass	Percent fat mass at baseline will be captured using the Tanita Body Fat Analyzer.	Baseline
Percent Fat Mass	Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.	9 weeks
Total Fat Mass	Total fat mass at baseline will be captured using the Tanita Body Fat Analyzer.	Baseline
Total Fat Mass	Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.	9 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Eugene Shapiro, MD, Yale School of Medicine; Principal Investigator: Ania M Jastreboff, MD, PhD, Yale School of Medicine; Principal Investigator: Robert S Sherwin, MD, Yale School of Medicine

Publications and helpful links

General Publications

• Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: glycemic index
• Other Study ID Numbers: 1604017520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED