Overweight and ObesityAQUAGLU-1NCT02932423
Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects
A study testing Test product A, Test product B and Test product C in people with Overweight and Obesity, run by Danone Global Research & Innovation Center at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Test product A, Test product B and Test product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2016to 21 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Overweight and Obesity
- Being tested
- Control product E, Test product A, Test product B, Test product C, Test product D
- Keywords
- Sugar-sweetened beverage, Overweight, Obese, Sugar, Water
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control product EOther
Plain water
Test product AOther
Beverage with no sugar but sweetener
Test product BOther
Beverage with 22 g/L sugar and sweetener
Test product COther
Beverage with 33 g/L sugar and sweetener
Test product DOther
Beverage with 47 g/L sugar and sweetener
Comparative product FOther
Beverage with 98 g/L sugar
| Study group | Role | What they receive |
|---|---|---|
| 1 - Snack | Other | 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. Receives: Other: Control product E; Other: Test product A; Other: Test product B; Other: Test product C; Other: Test product D; Other: Comparative product F |
| 2 - No snack | Other | 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. Receives: Other: Control product E; Other: Test product A; Other: Test product B; Other: Test product C; Other: Test product D; Other: Comparative product F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in maximum increment value of insulin concentration during first afternoon phase between each test product and the comparative product
Measured: 6 days (with 17 time points on each day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start18 Oct 2016
- Primary completion17 May 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanne BOTTIN, PhD, Study chair, Danone Research, Palaiseau, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932423
- Sponsor's protocol ID
- NU377
- Acronym
- AQUAGLU-1
- Status last verified
- Aug 2017
- First submitted
- 4 Oct 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02932423
- Acronym / sponsor ID
- AQUAGLU-1 / NU377
- Conditions
- Overweight and Obesity
- Keywords
- Sugar-sweetened beverage, Overweight, Obese, Sugar, Water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Snack | Other | Other: Control product E, Other: Test product A, Other: Test product B, Other: Test product C, Other: Test product D, Other: Comparative product FEach 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. |
| 2 - No snack | Other | Other: Control product E, Other: Test product A, Other: Test product B, Other: Test product C, Other: Test product D, Other: Comparative product FEach 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control product EPlain water | Other | 1 - Snack, 2 - No snack |
| Test product ABeverage with no sugar but sweetener | Other | 1 - Snack, 2 - No snack |
| Test product BBeverage with 22 g/L sugar and sweetener | Other | 1 - Snack, 2 - No snack |
| Test product CBeverage with 33 g/L sugar and sweetener | Other | 1 - Snack, 2 - No snack |
| Test product DBeverage with 47 g/L sugar and sweetener | Other | 1 - Snack, 2 - No snack |
| Comparative product FBeverage with 98 g/L sugar | Other | 1 - Snack, 2 - No snack |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne BOTTIN, PhD study chair
Danone Research, Palaiseau, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product A, Test product B and Test product C in people with Overweight and Obesity, run by Danone Global Research & Innovation Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.