Clinical trial NCT03613935: Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
Official title: Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a monocentric, controlled, randomized, open, complete crossover study design
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental Area under the Curve (iAUC) of plasma glucose
timeFrame: 0 to 3 hours post product intake
Secondary outcomes:
measure: Incremental Area under the Curve (iAUC) of plasma insulin
timeFrame: 0 to 3 hours post product intake
measure: Cmax of plasma glucose
timeFrame: between 0 and 3 hours post product intake
measure: Cmax of plasma insulin
timeFrame: between 0 and 3 hours post product intake
measure: Tmax of plasma glucose
timeFrame: between 0 and 3 hours post product intake
measure: Tmax of plasma insulin
timeFrame: between 0 and 3 hours post product intake
measure: Sensory tasting capacity
timeFrame: immediately after product intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Research Center
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References: