NCT04118257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

October 1, 2019

Last Update Submit

October 4, 2019

Conditions

Keywords

Glucose controlCardiovascular disease risk factorsSugary beveragesPulmonary function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in plasma lipids

    Week 0 and Week 3

  • Change in homeostatic model assessment for insulin resistance

    Week 0 and Week 3

  • Change in blood pressure

    Week 0 and Week 3

  • Change in BMI

    Week 0 and Week 3

  • Change in pulmonary function

    Week 0 and Week 3

  • +2 more secondary outcomes

Study Arms (3)

Fruit Juice

EXPERIMENTAL

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

Dietary Supplement: Sugary beverage: Fruit juice

Soda

EXPERIMENTAL

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

Dietary Supplement: Sugary beverage: Soda

Water

OTHER

Participants consumed 2 bottles of water daily for 3 weeks.

Dietary Supplement: Control: Water

Interventions

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

Fruit Juice
Sugary beverage: SodaDIETARY_SUPPLEMENT

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

Soda
Control: WaterDIETARY_SUPPLEMENT

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

Water

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lafene Health Center

Manhattan, Kansas, 66502, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sara Rosenkranz, PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 8, 2019

Study Start

February 10, 2017

Primary Completion

November 14, 2018

Study Completion

November 14, 2018

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations