NCT01714700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

October 18, 2012

Last Update Submit

September 9, 2014

Conditions

OverweightObesity

Keywords

proteinresistance exercise ghrelinoverweight

Outcome Measures

Primary Outcomes (1)

  • body composition

    BMI, and body fat percent

    12-week

Secondary Outcomes (6)

  • ghrelin

    12-week

  • Insulin resistance

    12-week

  • lipid parameter

    12-week

  • growth hormone

    12-week

  • hormone

    12-week

  • +1 more secondary outcomes

Study Arms (2)

High protein diet, Resistance exercise

ACTIVE COMPARATOR

High protein diet, Resistance exercise total calories 2400 Kcal/day, 55% carbohydrate, 30% protein, and 15% fat

Behavioral: High protein diet, Resistance exerciseBehavioral: Standard diet, Resistance exercise

Standard diet, Resistance exercise

PLACEBO COMPARATOR

total calories 2400 Kcal/day, 60% carbohydrate, 15% protein, and 25% fat; ST group

Behavioral: High protein diet, Resistance exerciseBehavioral: Standard diet, Resistance exercise

Interventions

High protein diet, Resistance exerciseBEHAVIORAL

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).

High protein diet, Resistance exerciseStandard diet, Resistance exercise
Standard diet, Resistance exerciseBEHAVIORAL

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)

High protein diet, Resistance exerciseStandard diet, Resistance exercise

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Eighteen healthy young males overweight

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Pusan, Ami-dong, 602-739, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24843767DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 26, 2012

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

May 1, 2007

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

KR(1)