Effects of Low Calorie Sweeteners on Dietary Intakes, Hun... | NCT02297880

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

NCT02297880

Sponsor

The Coca-Cola Company

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

170Actual

Phase

Not Applicable

Conditions

Eating Behavior

Interventions

Beverage containing low calorie sweeteners
Still water

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Nov 13, 2014

First Submission Date that Met QC Criteria

Nov 19, 2014

First Posted Date

Nov 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Name	Class
CreaBIO	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Beverage containing low calorie sweeteners	Other	Beverage containing low calorie sweeteners	Beverage containing low calorie sweeteners

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming		Givors	Lyon	69700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29526693	Derived	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.

ID	Term
D001522	Behavior, Animal
D001519	Behavior