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Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects (AQUAGLU-1)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control product E
Test product A
Test product B
Test product C
Test product D
Comparative product F
Sponsored by
Danone Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Sugar-sweetened beverage, Overweight, Obese, Sugar, Water

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study
  • 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:

  • Pregnant woman, based on positive urine pregnancy test, or planning to become pregnant during the study or breast-feeding woman
  • 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

Sites / Locations

  • Eurofins Optimed

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1 - Snack

2 - No snack

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean difference in maximum increment value of insulin concentration during first afternoon phase between each test product and the comparative product

Secondary Outcome Measures

Full Information

First Posted
October 4, 2016
Last Updated
August 21, 2017
Sponsor
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT02932423
Brief Title
Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects
Acronym
AQUAGLU-1
Official Title
Impact of Beverage Consumption With Varying Sweetening Systems During Meal on Post-prandial Glucose and Insulin Concentrations, and Lipid Metabolism in Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in overweight and obese subjects, during a 10-hour visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Sugar-sweetened beverage, Overweight, Obese, Sugar, Water

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Snack
Arm Type
Other
Arm Description
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.
Arm Title
2 - No snack
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control product E
Intervention Description
Plain water
Intervention Type
Other
Intervention Name(s)
Test product A
Intervention Description
Beverage with no sugar but sweetener
Intervention Type
Other
Intervention Name(s)
Test product B
Intervention Description
Beverage with 22 g/L sugar and sweetener
Intervention Type
Other
Intervention Name(s)
Test product C
Intervention Description
Beverage with 33 g/L sugar and sweetener
Intervention Type
Other
Intervention Name(s)
Test product D
Intervention Description
Beverage with 47 g/L sugar and sweetener
Intervention Type
Other
Intervention Name(s)
Comparative product F
Intervention Description
Beverage with 98 g/L sugar
Primary Outcome Measure Information:
Title
Mean difference in maximum increment value of insulin concentration during first afternoon phase between each test product and the comparative product
Time Frame
6 days (with 17 time points on each day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study 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: Pregnant woman, based on positive urine pregnancy test, or planning to become pregnant during the study or breast-feeding woman 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne BOTTIN, PhD
Organizational Affiliation
Danone Research, Palaiseau, France
Official's Role
Study Chair
Facility Information:
Facility Name
Eurofins Optimed
City
Gieres
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38610
Country
France

12. IPD Sharing Statement

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Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects

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