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

NCT03613935 | Completed

• 1 other identifier: 17.19.BIO
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incremental Area under the Curve (iAUC) of plasma glucose

  Area under the curve

  0 to 3 hours post product intake

Secondary Outcomes (6)

• Incremental Area under the Curve (iAUC) of plasma insulin

  0 to 3 hours post product intake

• Cmax of plasma glucose

  between 0 and 3 hours post product intake

• Cmax of plasma insulin

  between 0 and 3 hours post product intake

• Tmax of plasma glucose

  between 0 and 3 hours post product intake

• Tmax of plasma insulin

  between 0 and 3 hours post product intake

Study Arms (4)

Product 1

PLACEBO COMPARATOR

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

Other: Product 2; Other: Product 3; Other: Product 4

Product 2

ACTIVE COMPARATOR

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

Other: Product 1; Other: Product 3; Other: Product 4

Product 3

ACTIVE COMPARATOR

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

Other: Product 1; Other: Product 2; Other: Product 4

Product 4

ACTIVE COMPARATOR

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

Other: Product 1; Other: Product 2; Other: Product 3

Interventions

Product 1 OTHER

Comparison with products 2, 3, and 4

Product 2; Product 3; Product 4

Product 2 OTHER

Comparison with products 1, 3, and 4

Product 1; Product 3; Product 4

Product 3 OTHER

Comparison with products 1, 2, and 4

Product 1; Product 2; Product 4

Product 4 OTHER

Comparison with products 1, 2, and 3

Product 1; Product 2; Product 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestlé Research Center

Lausanne, 1000, Switzerland

Location

MeSH Terms

Interventions

LGI4 protein, human

Study Officials

• Maurice Beaumont, MD

  Société des Produits Nestlé (SPN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a monocentric, controlled, randomized, open, complete crossover study design

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 3, 2018
• Study Start: February 19, 2018
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

CH (1)