Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity

NCT ID: NCT02031497

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-12-31

Brief Summary

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

Detailed Description

Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to drink and food with few or no additional calories. Sweeteners are widely used in commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a reasonable level of consumption (less than 20 cans per day). However little data is available on the metabolic effects of a regular consumption of beverages containing sweeteners. The objective of the study is to evaluate the effect of a regular consumption (twice a day for 12 weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.

Conditions

Glucose Homeostasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Drink with sweeteners

Group Type: EXPERIMENTAL

Drink with sweeteners

Intervention Type: DIETARY_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 without sweeteners

Intervention Type: DIETARY_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 without sweeteners

Group Type: ACTIVE_COMPARATOR

Drink with sweeteners

Intervention Type: DIETARY_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 without sweeteners

Intervention Type: DIETARY_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.

Interventions

Drink with sweeteners

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.

Intervention Type: DIETARY_SUPPLEMENT

Drink without sweeteners

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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
• 19 kg/m² < BMI< 30 kg/m²

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute For European Expertise in Physiology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Bonnet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalo-Universitaire de Rennes

Fabrice Lainé, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalo-Universitaire de Rennes

Locations

Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

Rennes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29982723 (View on PubMed)

Other Identifiers

120901-10

Identifier Type: OTHER

Identifier Source: secondary_id

2012EL0905SEDULC

Identifier Type: -

Identifier Source: org_study_id