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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118257
• Other study ID #: Pro8531
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: November 14, 2018

Study information

• Verified date: October 2019
• Source: Kansas State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Sugary beverage: Fruit juice
Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.
• Sugary beverage: Soda
Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.
• Control: Water
Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.

Locations

Country	Name	City	State
United States	Lafene Health Center	Manhattan	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in homeostatic model assessment for insulin resistance	Calculated from fasting glucose and insulin values	Week 0 and Week 3
Secondary	Change in blood pressure	Evaluated via automated sphygmomanometer.	Week 0 and Week 3
Secondary	Change in BMI	Weight and height will be combined to report BMI in kg/m^2	Week 0 and Week 3
Secondary	Change in pulmonary function	Assessed using the maximum flow-volume loop	Week 0 and Week 3
Secondary	Change in insulin iAUC	Glucose obtained from blood sample in a fasted state and in response to a meal	Week 0 and Week 3
Secondary	Change in serum fructosamine	Fructosamine obtained from blood sample	Week 0 and Week 3