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

Glucose Homeostasis Clinical Trial

— SEDULC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031497
• Other study ID #: 2012EL0905SEDULC
• Secondary ID: 120901-10
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: March 2, 2017
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2017
• Source: Institute For European Expertise in Physiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Homeostasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Institute For European Expertise in Physiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Matsuda Insulin sensitivity Index		Before and after each of the two 12-week intervention period
Secondary	Insulinogenic Index defined as ? insulin 0-30 / ? glucose 0-30		Before and after each of the two 12-week intervention period
Secondary	Disposition index defined as Insulin sensitivity x insulinogenic Index		Before and after each of the two 12-week intervention period
Secondary	HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5		Before and after each of the two 12-week intervention period
Secondary	Dietary intake		Before and after each of the two 12-week intervention period
Secondary	Physical activity		Before and after each of the two 12-week intervention period