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OpenTrials
Completed

NCT Number: NCT02297880

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

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.

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Feeding Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming

Givors, Lyon, 69700, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beverage containing low calorie sweeteners

Other

Beverage containing low calorie sweeteners

Still water

Other

Still water (no flavour)

Primary outcomes

  1. Subjective sensations: hunger, satiety and desire to eat

    Time frame: 9 weeks

    Visual Analog Scales

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Coca-Cola Company

Industry

Collaborators

  • CreaBIO

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2014
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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