Beverage Consumption and Fine Motor Control (LCS)

March 19, 2019 updated by: Richard Mattes, Purdue University

The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake

The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 25-40 kg/M2
  • Non or rare users of LCS
  • Willing to consume large volumes of beverages daily

Exclusion Criteria:

  • Weight change > 3kg in the last year
  • Plan to initiate a new diet plan in the next 6 months
  • Exhibit eating restraint
  • Pregnant/lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sucrose Sweetened Beverage
100-140 g sucrose/day
Dietary supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Experimental: Aspartame Sweetened Beverage
0.541-0.757 g aspartame Sweetened Beverage/day
Dietary supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Experimental: Saccharin Sweetened Beverage
0.300-0.455 g saccharin Sweetened Beverage/day
Dietary supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Experimental: Sucralose Sweetened Beverage
0.167-0.233 g sucralose Sweetened Beverage/day
Dietary supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Experimental: Rebaudioside A Sweeteened Beverage
0.250-0.350 g rebaudioside A Sweetened Beverage/day
Dietary supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 12 weeks
12 weeks
Body Composition
Time Frame: 12 weeks
Duel emission X-ray absorbtiometry
12 weeks
Energy Intake
Time Frame: 12 weeks
24 hr Dietary Recall
12 weeks
Appetite
Time Frame: 12 weeks
24 hr visual analog scale appetite
12 weeks
Energy Expenditure
Time Frame: 12 weeks
accelerometer
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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