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

Eating Behavior Clinical Trial

Official title:

Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297880
• Other study ID #: CreaBIO1
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: February 8, 2017
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: The Coca-Cola Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Other:
• Beverage containing low calorie sweeteners
Beverage containing low calorie sweeteners
• Still water
Still water (no flavour)

Locations

Country	Name	City	State
France	CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming	Givors	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
The Coca-Cola Company	CreaBIO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sensations: hunger, satiety and desire to eat	Visual Analog Scales	9 weeks
Secondary	Energy and macronutrient intakes	Diet history questionnaire	9 weeks
Secondary	Anthropometric parameters	body weight, height, waist and hip circumferences	9 weeks