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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613935
• Other study ID #: 17.19.BIO
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: April 20, 2018

Study information

• Verified date: August 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Product 1
Comparison with products 2, 3, and 4
• Product 2
Comparison with products 1, 3, and 4
• Product 3
Comparison with products 1, 2, and 4
• Product 4
Comparison with products 1, 2, and 3

Locations

Country	Name	City	State
Switzerland	Nestlé Research Center	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Area under the Curve (iAUC) of plasma glucose	Area under the curve	0 to 3 hours post product intake
Secondary	Incremental Area under the Curve (iAUC) of plasma insulin	Area under the curve	0 to 3 hours post product intake
Secondary	Cmax of plasma glucose	Maximal concentration of plasma glucose	between 0 and 3 hours post product intake
Secondary	Cmax of plasma insulin	Maximal concentration of plasma insulin	between 0 and 3 hours post product intake
Secondary	Tmax of plasma glucose	Time (min) for maximal concentration of plasma glucose	between 0 and 3 hours post product intake
Secondary	Tmax of plasma insulin	Time (min) for maximal concentration of plasma insulin	between 0 and 3 hours post product intake
Secondary	Sensory tasting capacity	Assessment of the sweetness of two beverages versus control through a questionnaire	immediately after product intake