Healthy
Conditions
Brief summary
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
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.
Interventions
OTHERProduct 1
Comparison with products 2, 3, and 4
OTHERProduct 2
Comparison with products 1, 3, and 4
OTHERProduct 3
Comparison with products 1, 2, and 4
OTHERProduct 4
Comparison with products 1, 2, and 3
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a monocentric, controlled, randomized, open, complete crossover study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Area under the Curve (iAUC) of plasma glucose | 0 to 3 hours post product intake | Area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of plasma glucose | between 0 and 3 hours post product intake | Maximal concentration of plasma glucose |
| Cmax of plasma insulin | between 0 and 3 hours post product intake | Maximal concentration of plasma insulin |
| Incremental Area under the Curve (iAUC) of plasma insulin | 0 to 3 hours post product intake | Area under the curve |
| Tmax of plasma insulin | between 0 and 3 hours post product intake | Time (min) for maximal concentration of plasma insulin |
| Sensory tasting capacity | immediately after product intake | Assessment of the sweetness of two beverages versus control through a questionnaire |
| Tmax of plasma glucose | between 0 and 3 hours post product intake | Time (min) for maximal concentration of plasma glucose |
Countries
Switzerland
Outcome results
None listed