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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02932423
Acronym
AQUAGLU-1
Enrollment
48
Registered
2016-10-13
Start date
2016-10-18
Completion date
2017-07-21
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Sugar-sweetened beverage, Overweight, Obese, Sugar, Water

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.

Interventions

OTHERControl product E

Plain water

Beverage with no sugar but sweetener

Beverage with 22 g/L sugar and sweetener

Beverage with 33 g/L sugar and sweetener

Beverage with 47 g/L sugar and sweetener

OTHERComparative product F

Beverage with 98 g/L sugar

Sponsors

Danone Global Research & Innovation Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean difference in maximum increment value of insulin concentration during first afternoon phase between each test product and the comparative product6 days (with 17 time points on each day)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026