Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01714700
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2012-10-18
Brief Title:
Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise in Untrained Overweight Young Men
Sponsor:
Pusan National University Yangsan Hospital
Organization:
Pusan National University Yangsan Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2400 kcalday 60 carbohydrate 15 protein and 25 fat ST group and an interventional group with an isocaloric high protein diet total calories 2400 kcalday 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 30 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 0800 hours from each participants 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
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 2400 kcalday 60 carbohydrate 15 protein and 25 fat ST group and an interventional group with an isocaloric high protein diet total calories 2400 kcalday 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 30 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 0800 hours from each participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None