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Sugar-replacement Sweeteners, and Blood Sugar Control

NCT ID: NCT01128829

Last Updated: 2014-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-10-31

Brief Summary

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Several sugar-replacement sweeteners are currently on the market, including saccharine (ex. Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study is to examine wether non caloric sweeteners affects how well the body works to control blood sugar. The study includes detailed blood sugar testing after drinking liquids that may contain sucralose. The investigators hypothesize that drinking liquids with sucralose will effect the amounts of specific appetite-affecting substances naturally produced by the body.

Detailed Description

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Conditions

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Obesity

Keywords

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obesity diabetes artificial sweeteners

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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water-sucralose

Subjects in this group drank "water" 10 min before drinking a glucose load on their first oral glucose tolerance test (OGTT) and drank "sucralose" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week).

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

60 ml of water were drank 10 min before doing a OGTT

Sucralose

Intervention Type OTHER

60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT

sucralose-water

Subjects in this group drank "sucralose" 10 min before drinking a glucose load on their first OGTT and drank "water" 10 min before drinking a glucose load on their second OGTT. The two OGTT were separated on average by 1 week (i.e. washout was approximately 1 week).

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

60 ml of water were drank 10 min before doing a OGTT

Sucralose

Intervention Type OTHER

60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT

Interventions

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Water

60 ml of water were drank 10 min before doing a OGTT

Intervention Type OTHER

Sucralose

60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* body mass index (BMI) over 30.
* Homeostasis model assessment of insulin resistance (HOMA-IR) \< or = 2.6

Exclusion Criteria

* smoking or smoked within last six months
* pregnant or breastfeeding
* have malabsorptive syndromes
* intestinal inflammatory disease
* diabetes
* liver or kidney disease
* fructose intolerance
* consuming more than one can of diet beverage or one spoonful of non-nutritive sweeteners (e.g. sucralose, aspartame, or saccharine) a week.
* taking any medication that might affect metabolism or taste.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Marta Yanina Pepino de Gruev

Research Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Y Pepino de Gruev, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.

Reference Type DERIVED
PMID: 23633524 (View on PubMed)

Other Identifiers

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09-0583/ 201102383

Identifier Type: -

Identifier Source: org_study_id