NCT02297880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

November 13, 2014

Last Update Submit

February 8, 2017

Conditions

Keywords

low calorie sweetener satiety, intake, hunger

Outcome Measures

Primary Outcomes (1)

  • Subjective sensations: hunger, satiety and desire to eat

    Visual Analog Scales

    9 weeks

Secondary Outcomes (2)

  • Energy and macronutrient intakes

    9 weeks

  • Anthropometric parameters

    9 weeks

Study Arms (2)

Beverage containing low calorie sweeteners

EXPERIMENTAL

Beverage containing low calorie sweeteners (flavour)

Other: Beverage containing low calorie sweeteners

Still water

ACTIVE COMPARATOR

Still water (no flavour)

Other: Still water

Interventions

Beverage containing low calorie sweeteners

Beverage containing low calorie sweeteners

Still water (no flavour)

Still water

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming

Givors, Lyon, 69700, France

Location

Related Publications (1)

  • Fantino M, Fantino A, Matray M, Mistretta F. Beverages containing low energy sweeteners do not differ from water in their effects on appetite, energy intake and food choices in healthy, non-obese French adults. Appetite. 2018 Jun 1;125:557-565. doi: 10.1016/j.appet.2018.03.007. Epub 2018 Mar 9.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 21, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations