Clinical trial NCT02297880: Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety
Official title: Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Keywords: low calorie sweetener satiety, intake, hunger
Lead sponsor: The Coca-Cola Company
Sponsor class: INDUSTRY
Collaborators: name: CreaBIO
First posted: 2014-11-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Subjective sensations: hunger, satiety and desire to eat
timeFrame: 9 weeks
Secondary outcomes:
measure: Energy and macronutrient intakes
timeFrame: 9 weeks
measure: Anthropometric parameters
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Givors
country: France
facility: CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming
state: Lyon
Study officials:
References:
citation: 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.