Glycemic Index of Commonly Consumed Sweeteners

NCT ID: NCT02931578

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Glucose100

Participants in this arm will randomly receive 100% glucose in the OGTT drink 3 out of 9 visits.

Group Type ACTIVE_COMPARATOR

Glucose100

Intervention Type OTHER

Oral Glucose Tolerance Test

Intervention Type OTHER

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.

Glucose50

Participants in this arm will randomly receive 50% glucose in the OGTT drink 3 out of 9 visits.

Group Type ACTIVE_COMPARATOR

Glucose50

Intervention Type OTHER

Oral Glucose Tolerance Test

Intervention Type OTHER

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.

Glucose42

Participants in this arm will randomly receive 42% glucose in the OGTT drink 3 out of 9 visits.

Group Type ACTIVE_COMPARATOR

Glucose42

Intervention Type OTHER

Oral Glucose Tolerance Test

Intervention Type OTHER

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.

Interventions

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Glucose100

Intervention Type OTHER

Glucose50

Intervention Type OTHER

Glucose42

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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OGTT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Ania M Jastreboff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Robert S Sherwin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Center for Clinical Investigation Church Street Research Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11988062 (View on PubMed)

Other Identifiers

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1604017520

Identifier Type: -

Identifier Source: org_study_id

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