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

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Product 4; Other: Product 3; Other: Product 2; Other: Product 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03613935

17.19.BIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups, including a placebo group

Product 1

Placebo Comparator group

Description:

Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered

Treatment:

Other: Product 4

Other: Product 2

Other: Product 3

Product 2

Active Comparator group

Description:

Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered

Treatment:

Other: Product 4

Other: Product 1

Other: Product 3

Product 3

Active Comparator group

Description:

Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered

Treatment:

Other: Product 4

Other: Product 2

Other: Product 1

Product 4

Active Comparator group

Description:

Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered

Treatment:

Other: Product 2

Other: Product 1

Other: Product 3