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Completed

NCT Number: NCT02031497

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

Rennes, 35033 Rennes Cedex 9, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drink with sweeteners

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

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.

Primary outcomes

  1. Matsuda Insulin sensitivity Index

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

Secondary outcomes

  1. Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30

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

  2. Disposition index defined as Insulin sensitivity x insulinogenic Index

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

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

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

  4. Dietary intake

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

  5. Physical activity

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

Sponsors and collaborators

Lead sponsor

Institute For European Expertise in Physiology

Industry

Registry information

Acronym: SEDULC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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