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Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety

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ClinicalTrials.gov Identifier: NCT02297880
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
CreaBIO
Information provided by (Responsible Party):
The Coca-Cola Company

Brief Summary:
Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.

Condition or disease Intervention/treatment Phase
Eating Behavior Other: Beverage containing low calorie sweeteners Other: Still water Not Applicable

Detailed Description:
The study will be a monocentric randomized controlled open trial including two parallel groups to examine effects of LCS beverages as compared to water on daily intakes of energy and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the selection of sweet or savory foods eating occasions will be assessed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Beverage containing low calorie sweeteners
Beverage containing low calorie sweeteners (flavour)
Other: Beverage containing low calorie sweeteners
Beverage containing low calorie sweeteners

Active Comparator: Still water
Still water (no flavour)
Other: Still water
Still water (no flavour)




Primary Outcome Measures :
  1. Subjective sensations: hunger, satiety and desire to eat [ Time Frame: 9 weeks ]
    Visual Analog Scales


Secondary Outcome Measures :
  1. Energy and macronutrient intakes [ Time Frame: 9 weeks ]
    Diet history questionnaire

  2. Anthropometric parameters [ Time Frame: 9 weeks ]
    body weight, height, waist and hip circumferences



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index: Lower limit 18 kg/m²; Upper limit 28 kg/m²; weight stable within ± 3 kg in the last 6 months
  • Habitual energy intake within the 95% confident interval of the reference energy intake for the French population (as provided by the INCA 2 survey
  • Must not be a regular drinker of LCS beverages (less than once a week no more than every 15 days) and be willing to use LCS according to protocol
  • For female participants: not pregnant, not breast feeding, planning to become pregnant during the study or on contraception since at least 3 months (regular 28-day cycle)
  • Subject registered with the French Social Security.

Exclusion Criteria:

  • Currently diagnosed somatic pathology
  • On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months
  • Major psychiatric disorder, particularly eating disorders as defined by the Diagnostic and Statistical Manual od Mental Disorders-IV
  • Rejection of sweet foods or drinks as revealed by the diet history
  • Smoking subject planning to stop smoking in the next 3 months
  • Subjects suffering from food allergies or intolerance
  • Subject not capable of understanding the constraints of the study and who not agree to abide

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): NCT02297880


Locations
France
CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming
Givors, Lyon, France, 69700
Sponsors and Collaborators
The Coca-Cola Company
CreaBIO

Responsible Party: The Coca-Cola Company
ClinicalTrials.gov Identifier: NCT02297880     History of Changes
Other Study ID Numbers: CreaBIO1
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by The Coca-Cola Company:
low calorie sweetener satiety, intake, hunger