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Trial record 64 of 3084 for:    Area Under Curve AND Healthy

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

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ClinicalTrials.gov Identifier: NCT03613935
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Product 1 Other: Product 2 Other: Product 3 Other: Product 4 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a monocentric, controlled, randomized, open, complete crossover study design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Arm Intervention/treatment
Placebo Comparator: Product 1
Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
Other: Product 2
Comparison with products 1, 3, and 4

Other: Product 3
Comparison with products 1, 2, and 4

Other: Product 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
Other: Product 1
Comparison with products 2, 3, and 4

Other: Product 3
Comparison with products 1, 2, and 4

Other: Product 4
Comparison with products 1, 2, and 3

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
Comparison with products 2, 3, and 4

Other: Product 2
Comparison with products 1, 3, and 4

Other: Product 4
Comparison with products 1, 2, and 3

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
Comparison with products 2, 3, and 4

Other: Product 2
Comparison with products 1, 3, and 4

Other: Product 3
Comparison with products 1, 2, and 4




Primary Outcome Measures :
  1. Incremental Area under the Curve (iAUC) of plasma glucose [ Time Frame: 0 to 3 hours post product intake ]
    Area under the curve


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613935


Locations
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Switzerland
Nestlé Research Center
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Maurice Beaumont, MD Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03613935     History of Changes
Other Study ID Numbers: 17.19.BIO
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No