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OpenTrials
Completed

NCT Number: NCT04118257

Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors

Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lafene Health Center

Manhattan, Kansas, 66502, United States

About this study

In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Free from diagnosis of diabetes and pulmonary illness
  • Have no intake of glucose or lipid lowering medication.

Exclusion criteria

  • Smoke
  • Currently pregnant
  • Have bronchitis
  • Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).

Treatment and study plan

Sugary beverage: Fruit juice

Dietary Supplement

Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.

Sugary beverage: Soda

Dietary Supplement

Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.

Control: Water

Dietary Supplement

Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.

Primary outcomes

  1. Change in glucose iAUC

    Time frame: Week 0 and Week 3

    Glucose obtained from blood sample in a fasted state and in response to a meal

Secondary outcomes

  1. Change in plasma lipids

    Time frame: Week 0 and Week 3

    Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal

  2. Change in homeostatic model assessment for insulin resistance

    Time frame: Week 0 and Week 3

    Calculated from fasting glucose and insulin values

  3. Change in blood pressure

    Time frame: Week 0 and Week 3

    Evaluated via automated sphygmomanometer.

  4. Change in BMI

    Time frame: Week 0 and Week 3

    Weight and height will be combined to report BMI in kg/m^2

  5. Change in pulmonary function

    Time frame: Week 0 and Week 3

    Assessed using the maximum flow-volume loop

  6. Change in insulin iAUC

    Time frame: Week 0 and Week 3

    Glucose obtained from blood sample in a fasted state and in response to a meal

  7. Change in serum fructosamine

    Time frame: Week 0 and Week 3

    Fructosamine obtained from blood sample

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Registry information

Official study title

Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 8, 2019
Registry last updated
Oct 8, 2019

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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