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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Product 1; Other: Product 3; Other: Product 2; Other: Product 4

• Registration Number: NCT03613935
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2018-02-19
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Study First Submitted: 2018-07-09
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product 2	Product 1	Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
Product 2	Product 3	Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
Product 4	Product 2	Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered
Product 3	Product 2	Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
Product 4	Product 1	Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered
Product 1	Product 3	Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
Product 2	Product 4	Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
Product 1	Product 2	Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
Product 1	Product 4	Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
Product 3	Product 4	Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
Product 3	Product 1	Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
Product 4	Product 3	Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered

Primary Outcome Measures

Name	Time	Method
Incremental Area under the Curve (iAUC) of plasma glucose	0 to 3 hours post product intake	Area under the curve

Secondary Outcome Measures

Name	Time	Method
Incremental Area under the Curve (iAUC) of plasma insulin	0 to 3 hours post product intake	Area under the curve
Cmax of plasma insulin	between 0 and 3 hours post product intake	Maximal concentration of plasma insulin
Cmax of plasma glucose	between 0 and 3 hours post product intake	Maximal concentration of plasma glucose
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

Trial Locations

Locations (1)

Nestlé Research Center; 🇨🇭 Lausanne, Switzerland