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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Sugary beverage: Fruit juice; Dietary supplement: Sugary beverage: Soda; Dietary supplement: Control: Water

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Manhattan, Kansas, United States, 66502
      • Lafene Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fruit Juice; Participants consumed 2 bottles of 100% fruit juice daily for 3 weeks.	Dietary supplement: Sugary beverage: Fruit juice; Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.
EXPERIMENTAL: Soda; Participants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks.	Dietary supplement: Sugary beverage: Soda; Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.
OTHER: Water; Participants consumed 2 bottles of water daily for 3 weeks.	Dietary supplement: Control: Water; Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose iAUC	Glucose obtained from blood sample in a fasted state and in response to a meal	Week 0 and Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma lipids	Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal	Week 0 and Week 3
Change in homeostatic model assessment for insulin resistance	Calculated from fasting glucose and insulin values	Week 0 and Week 3
Change in blood pressure	Evaluated via automated sphygmomanometer.	Week 0 and Week 3
Change in BMI	Weight and height will be combined to report BMI in kg/m^2	Week 0 and Week 3
Change in pulmonary function	Assessed using the maximum flow-volume loop	Week 0 and Week 3
Change in insulin iAUC	Glucose obtained from blood sample in a fasted state and in response to a meal	Week 0 and Week 3
Change in serum fructosamine	Fructosamine obtained from blood sample	Week 0 and Week 3

Collaborators and Investigators

• Sponsor: Kansas State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2017
• Primary Completion (ACTUAL): November 14, 2018
• Study Completion (ACTUAL): November 14, 2018

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Glucose control; Pulmonary function; Cardiovascular disease risk factors; Sugary beverages
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: Pro8531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No