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Completed

NCT Number: NCT02932423

Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal 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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Optimed

Gières, Auvergne-Rhône-Alpes, 38610, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control product E

Other

Plain water

Test Product A

Other

Beverage with no sugar but sweetener

Test Product B

Other

Beverage with 22 g/L sugar and sweetener

Test Product C

Other

Beverage with 33 g/L sugar and sweetener

Test Product D

Other

Beverage with 47 g/L sugar and sweetener

Comparative product F

Other

Beverage with 98 g/L sugar

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study 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

Acronym: AQUAGLU-1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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