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

I

Institute For European Expertise in Physiology

Status

Completed

Conditions

Glucose Homeostasis

Treatments

Dietary Supplement: Drink with sweeteners
Dietary Supplement: Drink without sweeteners

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031497
120901-10 (Other Identifier)
2012EL0905SEDULC

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Drink with sweeteners
Experimental group
Treatment:
Dietary Supplement: Drink without sweeteners
Dietary Supplement: Drink with sweeteners
Drink without sweeteners
Active Comparator group
Treatment:
Dietary Supplement: Drink without sweeteners
Dietary Supplement: Drink with sweeteners

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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