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CompletedNCT03613935Updated Aug 3, 2018

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

An interventional study of Product 1 and Product 2 in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2018, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Placebo comparator
    Product 1

    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

  • Active comparator
    Product 2

    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

  • Active comparator
    Product 3

    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

  • 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 1 · Other: Product 2 · Other: Product 3

Interventions

  • OtherProduct 1

    Comparison with products 2, 3, and 4

  • OtherProduct 2

    Comparison with products 1, 3, and 4

  • OtherProduct 3

    Comparison with products 1, 2, and 4

  • OtherProduct 4

    Comparison with products 1, 2, and 3

06

What researchers measure

Primary outcomes

  1. Incremental Area under the Curve (iAUC) of plasma glucose

    Area under the curve

    Time frame: 0 to 3 hours post product intake

Secondary outcomes

  1. Incremental Area under the Curve (iAUC) of plasma insulin

    Area under the curve

    Time frame: 0 to 3 hours post product intake

  2. Cmax of plasma glucose

    Maximal concentration of plasma glucose

    Time frame: between 0 and 3 hours post product intake

  3. Cmax of plasma insulin

    Maximal concentration of plasma insulin

    Time frame: between 0 and 3 hours post product intake

  4. Tmax of plasma glucose

    Time (min) for maximal concentration of plasma glucose

    Time frame: between 0 and 3 hours post product intake

  5. Tmax of plasma insulin

    Time (min) for maximal concentration of plasma insulin

    Time frame: between 0 and 3 hours post product intake

  6. Sensory tasting capacity

    Assessment of the sweetness of two beverages versus control through a questionnaire

    Time frame: immediately after product intake

07

Study locations

1 site
  • Nestlé Research Center
    Lausanne, 1000, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03613935
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Feb 19, 2018
Primary completion
Apr 20, 2018
Completion
Apr 20, 2018
Last update
Aug 3, 2018

Study contacts

Maurice Beaumont, MD
principal investigator · Société des Produits Nestlé (SPN)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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