Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects
NCT ID: NCT02932423
Last Updated: 2017-08-22
Study Results
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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COMPLETED
NA
48 participants
INTERVENTIONAL
2016-10-18
2017-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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1 - Snack
Each subject will consume 6 beverages with varying sugar content at lunch (500 ml) and with a snack in the afternoon (330 ml). The 6 beverages (Test product A, Test product B, Test product C, Test product D, Control product E and Comparative product F) will correspond to the 6 interventions.
Control product E
Plain water
Test product A
Beverage with no sugar but sweetener
Test product B
Beverage with 22 g/L sugar and sweetener
Test product C
Beverage with 33 g/L sugar and sweetener
Test product D
Beverage with 47 g/L sugar and sweetener
Comparative product F
Beverage with 98 g/L sugar
2 - No snack
Each subject will consume 6 beverages with varying sugar content only at lunch (500 ml). The 6 beverages (Test product A, Test product B, Test product C, Test product D, Control product E and Comparative product F) will correspond to the 6 interventions.
Control product E
Plain water
Test product A
Beverage with no sugar but sweetener
Test product B
Beverage with 22 g/L sugar and sweetener
Test product C
Beverage with 33 g/L sugar and sweetener
Test product D
Beverage with 47 g/L sugar and sweetener
Comparative product F
Beverage with 98 g/L sugar
Interventions
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Control product E
Plain water
Test product A
Beverage with no sugar but sweetener
Test product B
Beverage with 22 g/L sugar and sweetener
Test product C
Beverage with 33 g/L sugar and sweetener
Test product D
Beverage with 47 g/L sugar and sweetener
Comparative product F
Beverage with 98 g/L sugar
Eligibility Criteria
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Inclusion Criteria
* Subject who is able to communicate well with the investigator and to comply with the requirements of the entire study
* If of child bearing potential, female subject must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively: oral birth control pills (at least 1 full monthly cycle prior to study product administration); intra-uterine device (IUD); double barrier methods (such as condoms and spermicide)
* Subject with a body mass index (BMI) between 25 and 35 kg/m² inclusive
Exclusion Criteria
* Surgical operation on digestive tract, except appendectomy
* Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks, or who plans to have one during the course of the study
* Subject with diagnosed or suspected allergy or hypersensitivity to any food ingredient, including components of the study products (ingredients of sugar-sweetened beverages)
* Blood donation within the last 3 months or planning to give blood during the course of the study
* Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study
* Subject in a situation, which in the Investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
* Evidence of clinically relevant cardiovascular, metabolic, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrine or psychiatric history of disease as determined by medical history, physical examination, and vital signs
* Clinically significant abnormal results for urine or blood analyses
25 Years
45 Years
ALL
No
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanne BOTTIN, PhD
Role: STUDY_CHAIR
Danone Research, Palaiseau, France
Locations
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Eurofins Optimed
Gières, Auvergne-Rhône-Alpes, France
Countries
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Other Identifiers
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NU377
Identifier Type: -
Identifier Source: org_study_id
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