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

February 8, 2017 updated by: The Coca-Cola Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lyon
      • Givors, Lyon, France, 69700
        • CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective sensations: hunger, satiety and desire to eat
Time Frame: 9 weeks
Visual Analog Scales
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy and macronutrient intakes
Time Frame: 9 weeks
Diet history questionnaire
9 weeks
Anthropometric parameters
Time Frame: 9 weeks
body weight, height, waist and hip circumferences
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Coca-Cola Company

Collaborators

CreaBIO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CreaBIO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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