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

August 21, 2017 updated by: Danone Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne-Rhône-Alpes
      • Gieres, Auvergne-Rhône-Alpes, France, 38610
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Control product E
Plain water
Other: Test product A
Beverage with no sugar but sweetener
Other: Test product B
Beverage with 22 g/L sugar and sweetener
Other: Test product C
Beverage with 33 g/L sugar and sweetener
Other: Test product D
Beverage with 47 g/L sugar and sweetener
Other: Comparative product F
Beverage with 98 g/L sugar
Other: 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.
Other: Control product E
Plain water
Other: Test product A
Beverage with no sugar but sweetener
Other: Test product B
Beverage with 22 g/L sugar and sweetener
Other: Test product C
Beverage with 33 g/L sugar and sweetener
Other: Test product D
Beverage with 47 g/L sugar and sweetener
Other: Comparative product F
Beverage with 98 g/L sugar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
6 days (with 17 time points on each day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Investigators

  • Study Chair: Jeanne BOTTIN, PhD, Danone Research, Palaiseau, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2016

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

July 21, 2017

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU377

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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