Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise on Body Composition, Ghrelin, and Metabolic and Hormonal Parameters in Untrained Overweight Young Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT01714700
First received: October 18, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

Background: The interactive effects of resistance training and dietary protein on hormonal responses in overweight or obese adults are not clear and remain controversial. Investigators tested the effect of an isocaloric high-protein diet on body composition, ghrelin, and metabolic and hormonal parameters during a 12-week resistance training program in untrained overweight healthy young men.

Methodology: Investigators randomized 18 healthy young males to a standard diet (ST group) or an isocaloric high protein diet (HP group). Subjects in both groups participated in a 12 week-resistance exercise program. Investigators measured body composition, lipid profile, homeostatic model assessment of insulin resistance (HOMA-IR) indices, total ghrelin, and exercise related hormones at baseline and 12 weeks.


Condition Intervention
Overweight
Obesity
Behavioral: Active Comparator-scheduled resistance exercise training program
Behavioral: placebo--scheduled resistance exercise training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pusan National University Yangsan Hospital:

Primary Outcome Measures:
  • body composition [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    BMI, and body fat percent

  • ghrelin [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    ghrelin


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    BP

  • Insulin resistance [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    HOMA-IR

  • lipid parameter [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    lipid

  • growth hormone [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    GH, IGF-1

  • hormone [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    testosterone

  • cortisol [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    cortisol


Enrollment: 18
Arms Assigned Interventions
Active Comparator: high protein diet
total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat; HP group
Behavioral: Active Comparator-scheduled resistance exercise training program
The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle).
Behavioral: placebo--scheduled resistance exercise training program
The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle)
Placebo Comparator: Placebo Comparator: standard diet
total calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group
Behavioral: Active Comparator-scheduled resistance exercise training program
The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle).
Behavioral: placebo--scheduled resistance exercise training program
The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Eighteen healthy young males overweight

Exclusion Criteria:

- participated in any weight-management program during the previous six months

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714700

Locations
Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Ami-dong, Korea, Republic of, 602-739
Sponsors and Collaborators
Pusan National University Yangsan Hospital
  More Information

No publications provided

Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT01714700     History of Changes
Other Study ID Numbers: GHRELIN0912
Study First Received: October 18, 2012
Last Updated: October 23, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Pusan National University Yangsan Hospital:
protein
resistance exercise ghrelin
overweight

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014