NCT02931578

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

October 7, 2016

Last Update Submit

November 25, 2019

Conditions

Healthy

Keywords

glycemic index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Body Mass Index (BMI)

    Baseline

  • Body Mass Index (BMI)

    9 weeks

  • Percent Fat Mass

    Baseline

  • Percent Fat Mass

    9 weeks

  • Total Fat Mass

    Baseline

  • +1 more secondary outcomes

Study Arms (3)

Glucose100

ACTIVE COMPARATOR

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

Other: Glucose100Other: Oral Glucose Tolerance Test

Glucose50

ACTIVE COMPARATOR

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

Other: Glucose50Other: Oral Glucose Tolerance Test

Glucose42

ACTIVE COMPARATOR

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

Other: Glucose42Other: Oral Glucose Tolerance Test

Interventions

Glucose100OTHER
Glucose100
Glucose50OTHER
Glucose50
Glucose42OTHER
Glucose42
Oral Glucose Tolerance TestOTHER

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.

Also known as: OGTT
Glucose100Glucose42Glucose50

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation Church Street Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 11988062BACKGROUND

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Eugene Shapiro, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Ania M Jastreboff, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Robert S Sherwin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

November 1, 2018

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

US(1)