NCT01674049

Brief Summary

The purpose of the proposed study is to examine the timing of post-exercise feeding on 15 hours post-exercise glycemic control and metabolic flexibility and in overweight and obese young men with a family history of type 2 diabetes. Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity, and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity both immediately and several hours post-ingestion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable type-2-diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

August 24, 2012

Last Update Submit

August 28, 2012

Conditions

Keywords

nutritionnutrienttimingdiabetesfamily historydairy

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    Continuous Glucose Monitoring was used for about 48 hours, from the time the participants entered the chamber on the control day through their release two days later

    48 hours

Secondary Outcomes (1)

  • Serum insulin

    2 hours post supplement ingestion

Study Arms (2)

Exercise and Immediate Nutrition

EXPERIMENTAL

40 min of circuit-style resistance exercise and 600g low-fat chocolate milk immediately after the exercise bout

Dietary Supplement: Immediate NutritionOther: Resistance Exercise

Exercise and Nutrition 3 hours Post-Bout

ACTIVE COMPARATOR

40 min of circuit-style resistance exercise and 600g low-fat chocolate milk three hours after the exercise bout

Dietary Supplement: Nutrition 3 hours Post-BoutOther: Resistance Exercise

Interventions

Immediate NutritionDIETARY_SUPPLEMENT

Nutritional supplement consumed either immediately following a 40min resistance exercise bout

Exercise and Immediate Nutrition
Nutrition 3 hours Post-BoutDIETARY_SUPPLEMENT

Nutritional supplement (600g low-fat chocolate milk) consumed three hours after the exercise bout

Exercise and Nutrition 3 hours Post-Bout

A single 40 minute circuit-style bout of resistance exercise

Exercise and Immediate NutritionExercise and Nutrition 3 hours Post-Bout

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI= 18-30
  • Report at least one first degree relative with family history of type 2 diabetes - Healthy with no self-report of diagnosis of chronic disease

You may not qualify if:

  • Self-report prior diagnosis of cardiovascular disease, pulmonary disease, adult asthma, dyspnea on exertion, current bronchitis, pneumonia, or tuberculosis, vascular disease, any intercurrent infection, hematologic/oncologic, any metastatic malignancy, anemia (hematocrit \<35), thrombocytopenia, neutropenia, hematologic malignancy, bleeding dyscrasias, neurologic disorder, endocrine disorder, chronic renal diseases
  • Any illegal drug use
  • Coumadin, heparin, beta blocker, growth hormone supplementation, or illegal drug use
  • Skeletal-muscular injury in the last 6 months (including severe sprains, broken bones, and tendon or ligament injuries)
  • Alcohol use in excess of 2 drinks per day
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Nutritional StatusResistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean L Gutierrez, PhD

    The George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 28, 2012

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations