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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugary beverage: Fruit juice
Sugary beverage: Soda
Control: Water
Sponsored by
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Glucose control, Cardiovascular disease risk factors, Sugary beverages, Pulmonary function

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Lafene Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Fruit Juice

Soda

Water

Arm Description

Participants consumed 2 bottles of 100% fruit juice daily for 3 weeks.

Participants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks.

Participants consumed 2 bottles of water daily for 3 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in homeostatic model assessment for insulin resistance
Calculated from fasting glucose and insulin values
Change in blood pressure
Evaluated via automated sphygmomanometer.
Change in BMI
Weight and height will be combined to report BMI in kg/m^2
Change in pulmonary function
Assessed using the maximum flow-volume loop
Change in insulin iAUC
Glucose obtained from blood sample in a fasted state and in response to a meal
Change in serum fructosamine
Fructosamine obtained from blood sample

Full Information

First Posted
October 1, 2019
Last Updated
October 4, 2019
Sponsor
Kansas State University
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1. Study Identification

Unique Protocol Identification Number
NCT04118257
Brief Title
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
Official Title
Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kansas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Glucose control, Cardiovascular disease risk factors, Sugary beverages, Pulmonary function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fruit Juice
Arm Type
Experimental
Arm Description
Participants consumed 2 bottles of 100% fruit juice daily for 3 weeks.
Arm Title
Soda
Arm Type
Experimental
Arm Description
Participants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks.
Arm Title
Water
Arm Type
Other
Arm Description
Participants consumed 2 bottles of water daily for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugary beverage: Fruit juice
Intervention Description
Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugary beverage: Soda
Intervention Description
Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control: Water
Intervention Description
Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.
Primary Outcome Measure Information:
Title
Change in glucose iAUC
Description
Glucose obtained from blood sample in a fasted state and in response to a meal
Time Frame
Week 0 and Week 3
Secondary Outcome Measure Information:
Title
Change in plasma lipids
Description
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
Time Frame
Week 0 and Week 3
Title
Change in homeostatic model assessment for insulin resistance
Description
Calculated from fasting glucose and insulin values
Time Frame
Week 0 and Week 3
Title
Change in blood pressure
Description
Evaluated via automated sphygmomanometer.
Time Frame
Week 0 and Week 3
Title
Change in BMI
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
Week 0 and Week 3
Title
Change in pulmonary function
Description
Assessed using the maximum flow-volume loop
Time Frame
Week 0 and Week 3
Title
Change in insulin iAUC
Description
Glucose obtained from blood sample in a fasted state and in response to a meal
Time Frame
Week 0 and Week 3
Title
Change in serum fructosamine
Description
Fructosamine obtained from blood sample
Time Frame
Week 0 and Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Rosenkranz, PhD
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lafene Health Center
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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