Glycemic Index of Commonly Consumed Sweeteners

Healthy Clinical Trial

Official title:

Glycemic Index of Commonly Consumed Sweeteners

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02931578
• Other study ID #: 1604017520
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Glucose100

• Glucose50

• Glucose42

• 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.

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation Church Street Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percent Fat Mass	Percent fat mass at baseline will be captured using the Tanita Body Fat Analyzer.	Baseline
Secondary	Percent Fat Mass	Percent fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.	9 weeks
Secondary	Total Fat Mass	Total fat mass at baseline will be captured using the Tanita Body Fat Analyzer.	Baseline
Secondary	Total Fat Mass	Total fat mass at 9 weeks will be captured using the Tanita Body Fat Analyzer.	9 weeks