NCT05000437

Brief Summary

Increased prevalence of overweight and obesity is one of the main health problems recently. Energy balance from nutrition intake and energy expenditure through physical activity, especially structured physical activity, is needed to prevent overweight individuals become obese individuals. This research objective is to explore the effectiveness and safety of structured high intensity interval training in male young adults subjects with overweight based on change of body composition, oxidative stress and inflammatory markers. This research used experimental model to test structured high intensity interval training program with pre-post test in single group. Comprehensive analysis of training effect in this research consists of measurement of several parameters, such as body composition, inflammatory markers, and oxidative stress markers as the benchmark of training safety. Browning white adipose tissue and cognitive function are complement parameters to the assessment of training effectiveness. Daily food record and physical activity for 3 x 24 hours will be carried out periodically to control confounding factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

November 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

May 29, 2021

Last Update Submit

March 7, 2023

Conditions

OverweightOverweight or Obesity

Keywords

high intensity interval trainingoverweightyoung male

Outcome Measures

Primary Outcomes (18)

  • cardiorespiratory fitness

    VO2Max in ml/kg/minute

    12 weeks

  • body mass index

    weight and height combined as BMI in kg/m2

    week 4

  • body mass index

    weight and height combined as BMI in kg/m2

    week 8

  • body mass index

    weight and height combined as BMI in kg/m2

    week 12

  • body fat mass

    total fat mass in the body as percentage

    week 4

  • body fat mass

    total fat mass in the body as percentage

    week 8

  • body fat mass

    total fat mass in the body as percentage

    week 12

  • visceral fat

    body fat stored within abdominal cavity as ratings

    week 4

  • visceral fat

    body fat stored within abdominal cavity as ratings

    week 8

  • visceral fat

    body fat stored within abdominal cavity as ratings

    week 12

  • waist circumference

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

    week 4

  • waist circumference

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

    week 8

  • waist circumference

    circumference measured in the horizontal plane midway between the lowest ribs and the iliac crest as cm

    week 12

  • lipid profile

    total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride

    12 weeks

  • antioxidant level

    SOD in U/mg

    12 weeks

  • free radicals level

    MDA in nmol/mg

    12 weeks

  • inflammation

    TNF-alpha in microgram/ml

    12 weeks

  • interleukin level

    IL-6 nanogram/ml

    12 weeks

Secondary Outcomes (5)

  • Fat Burning Effect

    week 1, 6, 12

  • Myokin

    week 1, 6, 12

  • Cognitive Function Screening

    week 1 and 12

  • Working memory Capacity

    week 1 and 12

  • Executive Function

    week 1 and 12

Study Arms (1)

High Intensity Interval Training

EXPERIMENTAL

single arm intervention, with high intensity interval training

Other: HIIT

Interventions

HIITOTHER

3x/week high intensity interval training for 12 weeks

High Intensity Interval Training

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overweight (BMI 25 - 29,9)
  • live in Jakarta and greater area
  • willing to participate

You may not qualify if:

  • smoking
  • any medical health problems (epilepsy, cardiovascular disease, kidney and liver problems, history of fractures, tendon and ligament injuries)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nani Sudarsono

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Sports Medicine Study Program

Study Record Dates

First Submitted

May 29, 2021

First Posted

August 11, 2021

Study Start

November 1, 2020

Primary Completion

October 30, 2021

Study Completion

December 31, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

ID(2)