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Beverage Consumption and Fine Motor Control (LCS)

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ClinicalTrials.gov Identifier: NCT02928653
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Body Weight Dietary Supplement: Beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
Study Start Date : December 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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




Primary Outcome Measures :
  1. Body Weight [ Time Frame: 12 weeks ]
  2. Body Composition [ Time Frame: 12 weeks ]
    Duel emission X-ray absorbtiometry

  3. Energy Intake [ Time Frame: 12 weeks ]
    24 hr Dietary Recall

  4. Appetite [ Time Frame: 12 weeks ]
    24 hr visual analog scale appetite

  5. Energy Expenditure [ Time Frame: 12 weeks ]
    accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928653


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Richard D Mattes, PhD Purdue University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Mattes, Distinguished Professor of Nutrition Sciences, Purdue University
ClinicalTrials.gov Identifier: NCT02928653    
Other Study ID Numbers: 055-044
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Richard Mattes, Purdue University:
energy intake
energy expenditure
appetite
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms