Beverage Consumption and Fine Motor Control
LCS
The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
1 other identifier
interventional
187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 21, 2019
March 1, 2019
2.2 years
October 5, 2016
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Body Weight
12 weeks
Body Composition
Duel emission X-ray absorbtiometry
12 weeks
Energy Intake
24 hr Dietary Recall
12 weeks
Appetite
24 hr visual analog scale appetite
12 weeks
Energy Expenditure
accelerometer
12 weeks
Study Arms (5)
Sucrose Sweetened Beverage
ACTIVE COMPARATOR100-140 g sucrose/day
Aspartame Sweetened Beverage
EXPERIMENTAL0.541-0.757 g aspartame Sweetened Beverage/day
Saccharin Sweetened Beverage
EXPERIMENTAL0.300-0.455 g saccharin Sweetened Beverage/day
Sucralose Sweetened Beverage
EXPERIMENTAL0.167-0.233 g sucralose Sweetened Beverage/day
Rebaudioside A Sweeteened Beverage
EXPERIMENTAL0.250-0.350 g rebaudioside A Sweetened Beverage/day
Interventions
Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Eligibility Criteria
You may qualify if:
- BMI between 25-40 kg/M2
- Non or rare users of LCS
- Willing to consume large volumes of beverages daily
You may not qualify if:
- Weight change \> 3kg in the last year
- Plan to initiate a new diet plan in the next 6 months
- Exhibit eating restraint
- Pregnant/lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Related Publications (1)
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.
PMID: 30997499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Mattes, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor of Nutrition Sciences
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 10, 2016
Study Start
December 1, 2015
Primary Completion
February 1, 2018
Study Completion
December 1, 2018
Last Updated
March 21, 2019
Record last verified: 2019-03