Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia

Study Overview
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Brief Summary
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Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness. In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.

Detailed Description
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After enrollment, participants will be asked to come to the investigational site 6 times for: two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency. 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.

Official Title
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Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia

Conditions
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Healthy

Intervention / Treatment
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* Other: Product 1
* Other: Product 2
* Other: Product 3
* Other: Product 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 18.5 and 29.9 kg/m2 Fasting capillary blood glucose level ≤ 7 mmol/L Able to understand and sign an informed consent form Exclusion Criteria: Pregnancy on anamnesis Lactating mothers Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin Family history of type 2 diabetes (parents) Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor) Known ageusia or other tasting trouble Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics) Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor Major medical/surgical event requiring hospitalisation in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Interventional Model Description: This is a monocentric, controlled, randomized, open, complete crossover study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Product 1<br>Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered | Other: Product 2<br>* Comparison with products 1, 3, and 4<br>Other: Product 3<br>* Comparison with products 1, 2, and 4<br>Other: Product 4<br>* Comparison with products 1, 2, and 3<br>|
| Active Comparator: Product 2<br>Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered | Other: Product 1<br>* Comparison with products 2, 3, and 4<br>Other: Product 3<br>* Comparison with products 1, 2, and 4<br>Other: Product 4<br>* Comparison with products 1, 2, and 3<br>|
| Active Comparator: Product 3<br>Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered | Other: Product 1<br>* Comparison with products 2, 3, and 4<br>Other: Product 2<br>* Comparison with products 1, 3, and 4<br>Other: Product 4<br>* Comparison with products 1, 2, and 3<br>|
| Active Comparator: Product 4<br>Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered | Other: Product 1<br>* Comparison with products 2, 3, and 4<br>Other: Product 2<br>* Comparison with products 1, 3, and 4<br>Other: Product 3<br>* Comparison with products 1, 2, and 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area under the Curve (iAUC) of plasma glucose | Area under the curve | 0 to 3 hours post product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area under the Curve (iAUC) of plasma insulin | Area under the curve | 0 to 3 hours post product intake | 
| Cmax of plasma glucose | Maximal concentration of plasma glucose | between 0 and 3 hours post product intake | 
| Cmax of plasma insulin | Maximal concentration of plasma insulin | between 0 and 3 hours post product intake | 
| Tmax of plasma glucose | Time (min) for maximal concentration of plasma glucose | between 0 and 3 hours post product intake | 
| Tmax of plasma insulin | Time (min) for maximal concentration of plasma insulin | between 0 and 3 hours post product intake | 
| Sensory tasting capacity | Assessment of the sweetness of two beverages versus control through a questionnaire | immediately after product intake |