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Completed

NCT Number: NCT03613935

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestlé Research Center

Lausanne, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Product 1

Other

Comparison with products 2, 3, and 4

Product 2

Other

Comparison with products 1, 3, and 4

Product 3

Other

Comparison with products 1, 2, and 4

Product 4

Other

Comparison with products 1, 2, and 3

Primary outcomes

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

    Time frame: 0 to 3 hours post product intake

    Area under the curve

Secondary outcomes

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

    Time frame: 0 to 3 hours post product intake

    Area under the curve

  2. Cmax of plasma glucose

    Time frame: between 0 and 3 hours post product intake

    Maximal concentration of plasma glucose

  3. Cmax of plasma insulin

    Time frame: between 0 and 3 hours post product intake

    Maximal concentration of plasma insulin

  4. Tmax of plasma glucose

    Time frame: between 0 and 3 hours post product intake

    Time (min) for maximal concentration of plasma glucose

  5. Tmax of plasma insulin

    Time frame: between 0 and 3 hours post product intake

    Time (min) for maximal concentration of plasma insulin

  6. Sensory tasting capacity

    Time frame: immediately after product intake

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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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