Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise 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: September 9, 2014
Last verified: September 2014
  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: High protein diet, Resistance exercise
Behavioral: Standard diet, Resistance exercise

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
Official Title: 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

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


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

  • 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
Study Start Date: August 2006
Study Completion Date: May 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High protein diet, Resistance exercise
High protein diet, Resistance exercise total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat
Behavioral: High protein diet, Resistance exercise
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: Standard diet, Resistance exercise
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: Standard diet, Resistance exercise
total calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group
Behavioral: High protein diet, Resistance exercise
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: Standard diet, Resistance exercise
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)

Detailed Description:

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). They have not participated in any weight-management program during the previous 6 months. An open-label design will be used. At enrolment, participants will randomly assign to one of two groups: a control group with a standard diet (total calories 2,400 kcal/day, 60% carbohydrate, 15% protein and 25% fat; ST group) and an interventional group with an isocaloric high protein diet (total calories 2,400 kcal/day, 55% carbohydrate, 30% protein and 15% fat; HP group). Participants in both groups take part in a scheduled resistance exercise training program. Participants does not take part in any other resistance training program or competitive sport over the study duration. At the start of the study, participants will be instructed to maintain their assigned diet throughout the study period. This will be assessed using a food frequency questionnaire (FFQ) with a 24-h recall after 12 weeks. Participants are presented with two-dimensional food pictures of the actual size of portions on a computer by a single trained dietitian to minimize interviewer bias. Medium are defined as the portion sizes shown, small are approximately half the medium portion size, and large are one-and-a-half times the medium portion size.

Exercise Protocol All participants will be under supervision during participation in the progressive supervised resistance exercise-training program. They participate in an onsite supervised protocol for 12 weeks (6 days per week). Exercise duration will be increased gradually, from 50 min at week 1 to 80 min at week 12, including warm-up for 20 min and cool-down periods for 10 min by carrying out gentle stretching exercises of the upper and lower limbs. A one repetition maximum (1-RM) is the maximum weight that can be lifted for one complete repetition of the movement. For each participant, the RM will be calculated for a particular muscle group. Each movement will be carried out at 60-80% of his 1-RM. Resistance will be increased slowly by three steps; step 1 (60-70% of his 1-RM for week 1-4), step 2 (65-75% of his 1-RM for week 5-8) and step 3 (70-80% of his 1-RM for week 9-12).

Baseline and Follow-up Measurements Height and bodyweight are measured using a digital scale with the examinee wearing a light gown, but no shoes. Body mass index (BMI) are calculated as weight (kg) divided by height squared (m2). The percentage body fat and total fat mass are measured by bioelectric impedance analysis (Inbody 3.0; Biospace Co., Ltd., Seoul, Korea), a sensitive test for quantification of changes in lean and fat mass in vivo and for assessment of regional fat distribution. A mercury sphygmomanometer are used for measurement of blood pressure (BP) of each participant, in the sitting position, after a 10-min resting period. Two readings each for the systolic and diastolic Bps are recorded at 3-min intervals, and the average of each measurement are included in our analysis.

Blood samples are obtained preprandially at 0.800 hours from each participant's antecubital vein after a 12-h fast, and are used for determination of plasma glucose, insulin, lipid profile, total ghrelin, GH, insulin-like growth factor-1 (IGF-1), testosterone and cortisol. Blood samples are obtained at baseline (prerandomization) and 12 weeks after randomization.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Sang Yeoup Lee, MD, PhD 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: September 9, 2014
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014