Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects (AQUAGLU-1)
Status
Completed
Conditions
Overweight and Obesity
Treatments
Other: Test product B
Other: Control product E
Other: Test product A
Other: Test product C
Other: Comparative product F
Other: Test product D
Details and patient eligibility
About
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.
Enrollment
48 patients
Sex
All
Ages
25 to 45 years old
Volunteers
No 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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
48 participants in 2 patient groups
1 - Snack
Other group
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.
Treatment:
Other: Test product C
Other: Control product E
Other: Test product A
Other: Comparative product F
Other: Test product B
Other: Test product D
2 - No snack
Other group
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.
Treatment:
Other: Test product C
Other: Control product E
Other: Test product A
Other: Comparative product F
Other: Test product B
Other: Test product D
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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