Glycemic Index of Commonly Consumed Sweeteners

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Other: Glucose50; Other: Glucose100; Other: Glucose42; Other: Oral Glucose Tolerance Test

• Registration Number: NCT02931578
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Primary Completion: 2017-12
• Study Completion: 2018-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose50	Glucose50	Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.
Glucose50	Oral Glucose Tolerance Test	Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.
Glucose100	Glucose100	Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.
Glucose100	Oral Glucose Tolerance Test	Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.
Glucose42	Glucose42	Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.
Glucose42	Oral Glucose Tolerance Test	Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.

Primary Outcome Measures

Name	Time	Method
Mean Glycemic Index	2 hours	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)

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	9 weeks	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)
Percent Fat Mass	9 weeks	Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.
Total Fat Mass	9 weeks	Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.

Trial Locations

Locations (1)

Yale Center for Clinical Investigation Church Street Research Unit; 🇺🇸 New Haven, Connecticut, United States