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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Product 2; Other: Product 3; Other: Product 4; Other: Product 1

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Nestlé Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Maurice Beaumont, MD, Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17.19.BIO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No