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:
Pusan National University Yangsan Hospital
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
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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 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 May 19, 2013