NCT02932423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

October 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

October 4, 2016

Last Update Submit

August 21, 2017

Conditions

Overweight and Obesity

Keywords

Sugar-sweetened beverageOverweightObeseSugarWater

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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.

Other: Control product EOther: Test product AOther: Test product BOther: Test product COther: Test product DOther: 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.

Other: Control product EOther: Test product AOther: Test product BOther: Test product COther: Test product DOther: Comparative product F

Interventions

Control product EOTHER

Plain water

1 - Snack2 - No snack
Test product AOTHER

Beverage with no sugar but sweetener

1 - Snack2 - No snack
Test product BOTHER

Beverage with 22 g/L sugar and sweetener

1 - Snack2 - No snack
Test product COTHER

Beverage with 33 g/L sugar and sweetener

1 - Snack2 - No snack
Test product DOTHER

Beverage with 47 g/L sugar and sweetener

1 - Snack2 - No snack
Comparative product FOTHER

Beverage with 98 g/L sugar

1 - Snack2 - No snack

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Optimed

Gières, Auvergne-Rhône-Alpes, 38610, France

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeanne BOTTIN, PhD

    Danone Research, Palaiseau, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 13, 2016

Study Start

October 18, 2016

Primary Completion

May 17, 2017

Study Completion

July 21, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

FR(1)