NCT02031497

Brief Summary

The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

January 8, 2014

Last Update Submit

March 2, 2017

Conditions

Glucose Homeostasis

Keywords

Sweetener, insulin, body mass index, physical activity

Outcome Measures

Primary Outcomes (1)

  • Matsuda Insulin sensitivity Index

    Before and after each of the two 12-week intervention period

Secondary Outcomes (5)

  • Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30

    Before and after each of the two 12-week intervention period

  • Disposition index defined as Insulin sensitivity x insulinogenic Index

    Before and after each of the two 12-week intervention period

  • HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5

    Before and after each of the two 12-week intervention period

  • Dietary intake

    Before and after each of the two 12-week intervention period

  • Physical activity

    Before and after each of the two 12-week intervention period

Study Arms (2)

Drink with sweeteners

EXPERIMENTAL
Dietary Supplement: Drink with sweetenersDietary Supplement: Drink without sweeteners

Drink without sweeteners

ACTIVE COMPARATOR
Dietary Supplement: Drink with sweetenersDietary Supplement: Drink without sweeteners

Interventions

Drink with sweetenersDIETARY_SUPPLEMENT

Subjects will have to consume a 330ml can of a drink with sweeteners twice per day as part of their usual fluid intake for 12 weeks.

Drink with sweetenersDrink without sweeteners
Drink without sweetenersDIETARY_SUPPLEMENT

Subjects will have to consume a 330ml can of a drink without sweeteners twice per day as part of their usual fluid intake for 12 weeks.

Drink with sweetenersDrink without sweeteners

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female
  • Subject taking at least three main meals (breakfast, lunch, dinner)
  • Subject able to understand and sign an informed consent
  • Subject drinking and enjoying soft drinks
  • Subject appreciating sweeteners taste
  • kg/m² \< BMI\< 30 kg/m²

You may not qualify if:

  • Any severe or acute illness that may influence the results of the study or may be life-threatening
  • Pregnant or breastfeeding subject
  • Past or present metabolic or digestive diseases, with the exception of a possible appendectomy
  • Diabetes or severe acute illness that may alter blood sugar
  • Treatment that may interfere with glucose homeostasis
  • Past or present kidney disease (renal failure, ... )
  • Local or systemic medication that may change water status, metabolism and feeding behavior
  • Antiplatelet treatment
  • Alcohol consumption ≥ 3-4 glasses / day ( ≥ 21 drinks / week )
  • Sustained physical exercise (more than 4 hours per week)
  • Subject adding sweeteners (tablets or powder) in their diet
  • Subject drinking more than two cans of drinks with sweeteners / day
  • Subject dieting to lose weight
  • Subject unable or unwilling to consume 2 liters of fluid / day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

Rennes, 35033 Rennes Cedex 9, France

Location

Related Publications (1)

  • Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Laine F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.

    PMID: 29982723DERIVED

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Interventions

Sweetening Agents

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fabrice Bonnet, MD, PhD

    Centre Hospitalo-Universitaire de Rennes

    PRINCIPAL INVESTIGATOR

  • Fabrice Lainé, MD, PhD

    Centre Hospitalo-Universitaire de Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

December 1, 2014

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

FR(1)