- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland, 1000
- Nestlé Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Product 1
Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
|
Active Comparator: Product 2
Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
|
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 4
|
Active Comparator: Product 3
Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 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
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 2, 3, and 4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental Area under the Curve (iAUC) of plasma glucose
Time Frame: 0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental Area under the Curve (iAUC) of plasma insulin
Time Frame: 0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
Cmax of plasma glucose
Time Frame: between 0 and 3 hours post product intake
|
Maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
Cmax of plasma insulin
Time Frame: between 0 and 3 hours post product intake
|
Maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
Tmax of plasma glucose
Time Frame: between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
Tmax of plasma insulin
Time Frame: between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
Sensory tasting capacity
Time Frame: immediately after product intake
|
Assessment of the sweetness of two beverages versus control through a questionnaire
|
immediately after product intake
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maurice Beaumont, MD, Société des Produits Nestlé (SPN)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17.19.BIO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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