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Beverage Consumption and Fine Motor Control (LCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date March 21, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
  • Body Weight [ Time Frame: 12 weeks ]
  • Body Composition [ Time Frame: 12 weeks ]
    Duel emission X-ray absorbtiometry
  • Energy Intake [ Time Frame: 12 weeks ]
    24 hr Dietary Recall
  • Appetite [ Time Frame: 12 weeks ]
    24 hr visual analog scale appetite
  • Energy Expenditure [ Time Frame: 12 weeks ]
    accelerometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beverage Consumption and Fine Motor Control
Official Title  ICMJE The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Body Weight
Intervention  ICMJE Dietary Supplement: Beverage
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Study Arms  ICMJE
  • Active Comparator: Sucrose Sweetened Beverage
    100-140 g sucrose/day
    Intervention: Dietary Supplement: Beverage
  • Experimental: Aspartame Sweetened Beverage
    0.541-0.757 g aspartame Sweetened Beverage/day
    Intervention: Dietary Supplement: Beverage
  • Experimental: Saccharin Sweetened Beverage
    0.300-0.455 g saccharin Sweetened Beverage/day
    Intervention: Dietary Supplement: Beverage
  • Experimental: Sucralose Sweetened Beverage
    0.167-0.233 g sucralose Sweetened Beverage/day
    Intervention: Dietary Supplement: Beverage
  • Experimental: Rebaudioside A Sweeteened Beverage
    0.250-0.350 g rebaudioside A Sweetened Beverage/day
    Intervention: Dietary Supplement: Beverage
Publications * Higgins KA, Mattes RD. A randomized controlled trial contrasting the effects of 4 low-calorie sweeteners and sucrose on body weight in adults with overweight or obesity. Am J Clin Nutr. 2019 May 1;109(5):1288-1301. doi: 10.1093/ajcn/nqy381.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
187
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2016)
200
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928653
Other Study ID Numbers  ICMJE 055-044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Richard Mattes, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard D Mattes, PhD Purdue University
PRS Account Purdue University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP