Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise in Untrained Overweight Young Men
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High protein diet, Resistance exercise
Standard diet, Resistance exercise
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring protein, resistance exercise ghrelin, overweight
Eligibility Criteria
Inclusion Criteria:
- Eighteen healthy young males overweight
Exclusion Criteria:
- participated in any weight-management program during the previous six months
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High protein diet, Resistance exercise
Standard diet, Resistance exercise
Arm Description
High protein diet, Resistance exercise total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat
total calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group
Outcomes
Primary Outcome Measures
body composition
BMI, and body fat percent
Secondary Outcome Measures
ghrelin
ghrelin
Insulin resistance
HOMA-IR
lipid parameter
lipid
growth hormone
GH, IGF-1
hormone
testosterone
cortisol
cortisol
Full Information
NCT ID
NCT01714700
First Posted
October 18, 2012
Last Updated
September 9, 2014
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01714700
Brief Title
Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise in Untrained Overweight Young Men
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
protein, resistance exercise ghrelin, overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High protein diet, Resistance exercise
Arm Type
Active Comparator
Arm Description
High protein diet, Resistance exercise total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat
Arm Title
Standard diet, Resistance exercise
Arm Type
Placebo Comparator
Arm Description
total calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group
Intervention Type
Behavioral
Intervention Name(s)
High protein diet, Resistance exercise
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard diet, Resistance exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
body composition
Description
BMI, and body fat percent
Time Frame
12-week
Secondary Outcome Measure Information:
Title
ghrelin
Description
ghrelin
Time Frame
12-week
Title
Insulin resistance
Description
HOMA-IR
Time Frame
12-week
Title
lipid parameter
Description
lipid
Time Frame
12-week
Title
growth hormone
Description
GH, IGF-1
Time Frame
12-week
Title
hormone
Description
testosterone
Time Frame
12-week
Title
cortisol
Description
cortisol
Time Frame
12-week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Eighteen healthy young males overweight
Exclusion Criteria:
- participated in any weight-management program during the previous six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
State/Province
Ami-dong
ZIP/Postal Code
602-739
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24843767
Citation
Kim HH, Kim YJ, Lee SY, Jeong DW, Lee JG, Yi YH, Cho YH, Choi EJ, Kim HJ. Interactive effects of an isocaloric high-protein diet and resistance exercise on body composition, ghrelin, and metabolic and hormonal parameters in untrained young men: A randomized clinical trial. J Diabetes Investig. 2014 Mar 23;5(2):242-7. doi: 10.1111/jdi.12148. Epub 2013 Oct 10.
Results Reference
derived
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Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise in Untrained Overweight Young Men
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