NCT03576703

Brief Summary

The objective of this study was to determine how metabolic and inflammatory effects of physical exercise in overweight individuals are altered when sugar-sweetened beverages (SSB) are consumed after physical exercise. A randomized, controlled crossover trial was performed in which participants performed exercise with and without the ingestions of SSB during exercise or a non-exercise control condition to evaluate metabolic and inflammatory responses one day after the exercise and or SSB treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

June 26, 2018

Last Update Submit

June 26, 2018

Conditions

Keywords

metabolic syndromeinflammationinsulin sensitivitymetabolic flexibilityoverweight/obese

Outcome Measures

Primary Outcomes (3)

  • Glucose tolerance

    75 g oral glucose tolerance test with measurement of glucose and insulin

    2 hours

  • Metabolic flexibility

    Change in respiratory exchange ratio in response to ingestion of 75 g of glucose

    2 hours

  • Inflammation

    Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose

    2 hours

Study Arms (3)

EX+H2O

EXPERIMENTAL

Exercise and diet that did not include SSB

Other: Exercise with and without SSB ingestion

EX+SSB

EXPERIMENTAL

Exercise and diet that includes SSB

Other: Exercise with and without SSB ingestion

CONTROL

NO INTERVENTION

No exercise and diet that did not include SSB

Interventions

Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control

EX+H2OEX+SSB

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 25 and \< 35 kg/m2
  • sedentary to moderately active

You may not qualify if:

  • inflammatory conditions
  • heart disease, diabetes, and other diseases that may interfere with the safety of exercise or other experimental procedures
  • allergy to wheat, gluten, dairy, or peanuts
  • taking blood pressure, cholesterol lowering, or anti-inflammatory medications
  • taking hormone-based birth control with exception of intrauterine device,
  • pregnant
  • health concerns that make it difficult to participate in study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationInsulin ResistanceMetabolic SyndromeOverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mary P Miles, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: randomized crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 3, 2018

Study Start

October 24, 2014

Primary Completion

July 9, 2015

Study Completion

July 9, 2015

Last Updated

July 3, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share