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

Overweight and Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932423
• Other study ID #: NU377
• Status: Completed
• Phase: N/A
• First received: October 4, 2016
• Last updated: August 21, 2017
• Start date: October 18, 2016
• Est. completion date: July 21, 2017

Study information

• Verified date: August 2017
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 21, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Eurofins Optimed	Gieres	Auvergne-Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in maximum increment value of insulin concentration during first afternoon phase between each test product and the comparative product		6 days (with 17 time points on each day)