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

Not Applicable

Completed

• Conditions: Eating Behavior
• Interventions: Other: Still water; Other: Beverage containing low calorie sweeteners

• Registration Number: NCT02297880
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Still water	Still water	Still water (no flavour)
Beverage containing low calorie sweeteners	Beverage containing low calorie sweeteners	Beverage containing low calorie sweeteners (flavour)

Primary Outcome Measures

Name	Time	Method
Subjective sensations: hunger, satiety and desire to eat	9 weeks	Visual Analog Scales

Secondary Outcome Measures

Name	Time	Method
Energy and macronutrient intakes	9 weeks	Diet history questionnaire
Anthropometric parameters	9 weeks	body weight, height, waist and hip circumferences

Trial Locations

Locations (1)

CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming; 🇫🇷 Givors, Lyon, France