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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Eating Behavior

Intervention / Treatment
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* Other: Beverage containing low calorie sweeteners
* Other: Still water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beverage containing low calorie sweeteners<br>Beverage containing low calorie sweeteners (flavour) | Other: Beverage containing low calorie sweeteners<br>* Beverage containing low calorie sweeteners<br>|
| Active Comparator: Still water<br>Still water (no flavour) | Other: Still water<br>* Still water (no flavour)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low calorie sweetener satiety, intake, hunger