Expired Study
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Lubbock, Texas 79423


Purpose:

Study the responses of circulatory irisin to chronic high-intensity resistance training


Study summary:

Objective: The purpose of this study is to study the circulating levels of irisin in response to chronic high-intensity resistance training in a group of healthy young adults. Sample: The sample will be comprised 44 of adult men and women unpaid volunteers between the ages of 18 and 30. Pre-screening assessments: Informed consent, PAR-Q, Medical History and Exercise History will be used to determine health status and prior exercise experience. Menstrual cycle log will be required for female participants. Pre-Intervention assessments: - Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition. - Cardiopulmonary and Strength Fitness Testing. Cardiopulmonary fitness will be determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness. - Spontaneous Physical Activity: Daily activity level for 7 days will be collected. - Familiarization. Participant will be instructed on the muscle conditioning techniques used for strength training so that the techniques can be mastered. The rate of perceived exertion (RPE) scale will also be used for familiarization during these sessions. Intervention: The intervention will last 3 weeks with a frequency of 3 training session per week. We will collect blood samples levels at session 1 (at the beginning of week 1), session 3 (at the end of week 1), at session 6 (at the end of week 2) and session 9 (at the end of week 3). Blood draws will occur at the beginning of each session evaluated (pre-session), at the 45 min mark during each session and immediately after each session (post-session). The sessions will consist on a circuit training of 3 sets of 7 exercises focused on major muscle groups. Ten repetitions on each circuit at 70% of the maximum capacity will be performed. During the intervention: - Blood-related variables. Baseline glucose, lactate and hematocrit will be obtained from all participants prior to intervention. Lactate and Hematocrit will be obtained pre-intervention and post-intervention, and within 1 min post workout at sessions 1, 3, 6 and 9. Irisin will be obtained from blood samples at baseline, during and after training sessions 1, 3, 6 and 9. Irisin will be measured via a commercial enzyme-linked immunosorbent assay. - Dietary Controls. Each participant will complete the Food Preference Questionnaire. In addition, the Automated Self-Administered 24-hour Recall (ASA24) will be collected for the days prior to sessions 1, 3, 6 and 9. Post-Intervention assessments: - Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition. - Caridorespiratory capacity determined via maximum oxygen uptake testing. One maximum repetition (1-RM) will be used to assess the muscular fitness. - Spontaneous Physical Activity: Daily activity level for 7 days will be collected.


Criteria:

Exclusion Criteria: - Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded. - Pregnant females. - Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study. - Individuals found to be less than 110 pounds. - Participants that exercise more than three times per week or strength train more than twice per week. - Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded. - Cigarette smoking (current or those who quit within the previous 6 months - Hypertension - Overweight and obese - Pre-diabetics


Study is Available At:


Original ID:

504792B


NCT ID:

NCT02475473


Secondary ID:


Study Acronym:


Brief Title:

Circulatory Levels of Irisin in Response to Chronic Resistance Training


Official Title:

Circulatory Levels of Irisin in Response to Chronic Resistance Training


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Texas Tech University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Maria Fernandez del Valle, PhD
Principal Investigator
Texas Tech University

Study Dates

Start Date:February 2015
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:September 2015
Last Changed Date:October 19, 2015
First Received Date:February 3, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Physical Activity assessment: accelerometry
Time Frame:3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Diet assessment: 24 hour recall and Food Preference Questionnaire
Time Frame:3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Changes in Hematocrit concentration
Time Frame:Baseline and 3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Changes in Blood glucose levels
Time Frame:Baseline and 3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Changes in Body composition assessment: DEXA and anthropometry
Time Frame:Baseline and 3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Changes in physical fitness levels as meassured by 1RM (repetition maximum) and Cardio-respiratory maximal testing
Time Frame:Baseline and 3 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Blood Lactate levels
Time Frame:3 weeks
Safety Issues:False
Description:Intensity of exercise on sessions 1, 3, 6 and 9
Outcome Type:Primary Outcome
Measure:Change in Serum irisin levels
Time Frame:Baseline and 3 weeks
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Exercise Training
Description:Chronic High-Intensity Resistance Training
Arm Name:Intervention

Study Arms

Study Arm Type:No Intervention
Arm Name:Control
Description:Control
Study Arm Type:Experimental
Arm Name:Intervention
Description:The acute intervention will consist of 1 session of training following the program: Resistance Training Exercises. Each participant in the intervention group will perform resistance-training exercises in the form of a circuit. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the es

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Texas Tech University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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