Completed

Nutrient Timing Following Resistance Exercise in Young Overweight and Obese Young Men With a Family History of Diabetes

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What is being tested

Immediate Nutrition

+ Resistance Exercise

+ Nutrition 3 hours Post-Bout

Dietary SupplementOther
Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 35 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorGeorge Washington University
Last updated: August 29, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

The proposed study is cross-sectional and utilizes a within-subject design to study young men under two different nutrient timing protocols, which are randomly-ordered and spaced at least 2 weeks apart. Participants will be screened for eligibility via phone or email and scheduled for an initial visit, in order to consent to the study and undergo some basic baseline evaluations. We will rely on participant self-report to verify absence of chronic disease or drug use. After consenting to the study, fasting blood glucose, height, weight, and air displacement plethysmography (BodPod®) will be conducted in the Clinical Exercise Physiology Laboratory at The George Washington University, in Washington, DC. These measures may occur on the same day as consent or at another scheduled time. After screening, consenting, and baseline assessments, participants will undergo 2 experimental conditions, which will be randomly-ordered and approximately 2 weeks apart. If possible, both of these experimental visits will be scheduled shortly after the consent form is signed. A registered dietitian will instruct participants to eat a standardized (35 kcal∙kg body weight-1∙day-1) diet comprising 60% carbohydrate, 20% protein, and 20% fat for 3 days prior to both experimental sessions. This instruction will be administered after the BodPod® assessment is completed. Participants will report to the USDA Laboratory chamber at 7:30 AM for the experimental sessions. Height, weight blood pressure and heart rate will be measured, then a fasting blood sample (5 cc) will be obtained for determination of basal glucose & insulin concentrations. A Hidalgo Ambulatory Monitoring Sensor Array Vest (Equivital I: Hidalgo Ltd., Cambridge UK) will be worn by all participants measured in the calorimeter for the entire 48 period. This device measures heart rate (HR), heat flux, core body temperature, posture and physical activity (PA) from a built-in accelerometer. Then, the sensor portion of the CGMS then will be placed subcutaneously and the CGMS calibrated with whole blood using the Accu-Check Advantage (Roche Diagnostics, Indianapolis, IL) glucometer. Participants will then enter the whole room calorimeter (metabolic chamber) and complete a hunger scale. Hunger will be evaluated 10-20 minutes before the start of each meal and 2 hours after the resistance exercise bout. On the first day, participants eat a standard breakfast provided by the USDA kitchen at approximately 7:45-8:00AM. Gutierrez or a research assistant will take obtain glucometer readings before and 60 minutes after each meal to calibrate the the CGMS. These evaluations will occur 4-6 times over the course of the day. Standardized meals (lunch at 11:00AM and dinner at 7:00PM) will be provided for subjects by the USDA. Blood samples (5 cc each) will be collected prior to and 120 minutes after breakfast and lunch; and prior to and 30-, 60-, 90-, and 120-min following the start of the evening meal for the determination of post-meal responses in glucose & insulin. A trained phlebotomist with at least 50 successful IV catheter placements will place an IV catheter into the participant's median antecubital vein before the evening meal to facilitate multiple draws after the meal. On the second day, subjects will awake in the calorimeter at approximately 7:00 AM and a fasting blood sample (5 cc) will be obtained for determination of basal concentrations of glucose & insulin. At about 7:30 AM, subjects will eat a standardized breakfast to be consumed by 8:00 AM. Two hours after a standardized lunch meal, served at 11:00AM, participants will perform one of the following resistance exercise nutrient-timing protocols: immediate post-exercise nutrition at approximately 2:00 PM 3 hour post exercise nutrition at approximately 5:00 PM). All participants will undergo both experimental conditions at different testing sessions.

Principal SponsorGeorge Washington University
Last updated: August 29, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

2 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
Alcohol use in excess of 2 drinks per day

Any illegal drug use

Coumadin, heparin, beta blocker, growth hormone supplementation, or illegal drug use

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The George Washington University

Washington D.C., United StatesOpen The George Washington University in Google Maps
CompletedOne Study Center