NCT04910763

Brief Summary

The purpose of the study is to learn about how type of exercise influences measures of appetite regulation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

June 12, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

April 19, 2021

Last Update Submit

October 13, 2022

Conditions

PreDiabetesAppetitive Behavior

Keywords

Resistance ExercisePre DiabetesAppetite

Outcome Measures

Primary Outcomes (2)

  • Changes in Appetite Rating

    Hunger/Satiety before/after consumption of a meal

    Baseline: Pre-Meal , 30 minutes, 60 minutes, 90 minutes, and 120 minutes post meal / Post-intervention(Week 4) :Pre-Meal, 30 minutes, 60 minutes, 90 minutes ,and 120 minutes post meal

  • Changes in Hormonal Response to Feeding

    Assessment of Ghrelin levels analyzed in blood samples before/after feeding.

    Baseline: Pre-Meal , 30 minutes, 60 minutes, 90 minutes, and 120 minutes post meal / Post-intervention(Week 4) :Pre-Meal, 30 minutes, 60 minutes, 90 minutes ,and 120 minutes post meal

Secondary Outcomes (8)

  • Changes in Body Composition

    Baseline and Post-intervention(Week 4)

  • Changes in Maximal Strength

    Baseline and Post-intervention(Week 4)

  • Changes in Physical Activity Levels

    Baseline and Post-intervention(Week 4)

  • Changes in Food-Related Behaviors

    Baseline and Post-intervention(Week 4)

  • Changes in Food-Related Behaviors

    Baseline and Post-intervention(Week 4)

  • +3 more secondary outcomes

Study Arms (1)

Resistance Exercise

EXPERIMENTAL

Resistance exercise will be training all major muscle groups 2x/week (2 days upper body, 2 days lower body) at 40-50% 1 repetition max (RM; estimated from 10 RM baseline testing) for 3 sets of 10-12 reps. This equals 4x/week for the 3 week intervention period.

Behavioral: Resistance Exercise

Interventions

Resistance ExerciseBEHAVIORAL

Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.

Resistance Exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years of age
  • BMI between 27-40 kg/m²
  • Hemoglobin A1c level between 5.7% and 6.4%
  • Physical Activity (less than 150 min/week moderate-intensity Physical Activity, no more than 1 session/week of resistance exercise)

You may not qualify if:

  • Unstable Cardiovascular Disease
  • Uncontrolled hypertension
  • Severe hypertriglyceridemia
  • History of or active liver disease
  • Uncontrolled thyroid disease
  • Active cancer diagnosis
  • Smoking
  • Engaged in exercise or diet program
  • History of bariatric surgery
  • GI malabsorptive disorders
  • Significant diet intolerances
  • History of major psychiatric disorder
  • presence of alcohol or substance abuse;
  • medications affecting weight,
  • EI or EE in past 6 months;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prediabetic StateAppetitive BehaviorGlucose Intolerance

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehaviorHyperglycemia

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tanya M Halliday, PhD, RD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants are randomly assigned to one of the two intervention groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD, RD

Study Record Dates

First Submitted

April 19, 2021

First Posted

June 2, 2021

Study Start

June 12, 2019

Primary Completion

September 3, 2021

Study Completion

September 28, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations

US(1)