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OverweightNCT01714700

Interactive Effects of an Isocaloric High-protein Diet and Resistance Exercise in Untrained Overweight Young Men

A study testing High protein diet, Resistance exercise and Standard diet, Resistance exercise in people with Overweight and Obesity, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
High protein diet, Resistance exercise and Standard diet, Resistance exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteSouth Korea
Study dates
Aug 2006to May 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eighteen healthy young males overweight

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Pusan National University Yangsan Hospital

    Pusan, Ami-dong, 602-739

Other trials in South Korea

About this study

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

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.

Read the 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.

Conditions
Overweight, Obesity
Being tested
High protein diet, Resistance exercise, Standard diet, Resistance exercise
Keywords
protein, resistance exercise ghrelin, overweight
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High protein diet, Resistance exerciseBehavioural

    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).

  • Standard diet, Resistance exerciseBehavioural

    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)

Study groups in NCT01714700
Study groupRoleWhat they receive
High protein diet, Resistance exerciseActive comparatorHigh protein diet, Resistance exercise total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat
Receives: Behavioral: High protein diet, Resistance exercise; Behavioral: Standard diet, Resistance exercise
Standard diet, Resistance exercisePlacebo comparatortotal calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group
Receives: Behavioral: High protein diet, Resistance exercise; Behavioral: Standard diet, Resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body composition

    BMI, and body fat percent

    Measured: 12-week

Secondary outcomes (6)
  1. ghrelin

    ghrelin

    Measured: 12-week

  2. Insulin resistance

    HOMA-IR

    Measured: 12-week

  3. lipid parameter

    lipid

    Measured: 12-week

  4. growth hormone

    GH, IGF-1

    Measured: 12-week

  5. hormone

    testosterone

    Measured: 12-week

  6. cortisol

    cortisol

    Measured: 12-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startAug 2006
  3. Primary completionMar 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714700
Sponsor's protocol ID
GHRELIN0912
Status last verified
Sep 2014
First submitted
18 Oct 2012
Last updated
10 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24843767

Questions about this trial

What is this clinical trial studying?

A study testing High protein diet, Resistance exercise and Standard diet, Resistance exercise in people with Overweight and Obesity, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body composition (time frame: 12-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.

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