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

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

Study Overview

• Status: Completed
• Conditions: Glucose Homeostasis
• Intervention / Treatment: Dietary supplement: Drink with sweeteners; Dietary supplement: Drink without sweeteners

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033 Rennes Cedex 9
    • Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drink with sweeteners	Dietary supplement: 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.; 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.
Active Comparator: Drink without sweeteners	Dietary supplement: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Matsuda Insulin sensitivity Index	Before and after each of the two 12-week intervention period

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute For European Expertise in Physiology
• Investigators: Principal Investigator: Fabrice Bonnet, MD, PhD, Centre Hospitalo-Universitaire de Rennes; Study Director: Fabrice Lainé, MD, PhD, Centre Hospitalo-Universitaire de Rennes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Sweetener, insulin, body mass index, physical activity
• Other Study ID Numbers: 2012EL0905SEDULC; 120901-10 (Other Identifier: ANSM)