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

NCT ID: NCT03613935

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2018-04-20

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a monocentric, controlled, randomized, open, complete crossover study design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Product 1

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

Group Type PLACEBO_COMPARATOR

Product 2

Intervention Type OTHER

Comparison with products 1, 3, and 4

Product 3

Intervention Type OTHER

Comparison with products 1, 2, and 4

Product 4

Intervention Type OTHER

Comparison with products 1, 2, and 3

Product 2

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

Group Type ACTIVE_COMPARATOR

Product 1

Intervention Type OTHER

Comparison with products 2, 3, and 4

Product 3

Intervention Type OTHER

Comparison with products 1, 2, and 4

Product 4

Intervention Type OTHER

Comparison with products 1, 2, and 3

Product 3

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

Group Type ACTIVE_COMPARATOR

Product 1

Intervention Type OTHER

Comparison with products 2, 3, and 4

Product 2

Intervention Type OTHER

Comparison with products 1, 3, and 4

Product 4

Intervention Type OTHER

Comparison with products 1, 2, and 3

Product 4

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

Group Type ACTIVE_COMPARATOR

Product 1

Intervention Type OTHER

Comparison with products 2, 3, and 4

Product 2

Intervention Type OTHER

Comparison with products 1, 3, and 4

Product 3

Intervention Type OTHER

Comparison with products 1, 2, and 4

Interventions

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Product 1

Comparison with products 2, 3, and 4

Intervention Type OTHER

Product 2

Comparison with products 1, 3, and 4

Intervention Type OTHER

Product 3

Comparison with products 1, 2, and 4

Intervention Type OTHER

Product 4

Comparison with products 1, 2, and 3

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Beaumont, MD

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé (SPN)

Locations

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Nestlé Research Center

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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17.19.BIO

Identifier Type: -

Identifier Source: org_study_id

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