NCT04794309

Brief Summary

Obesity is one of the common public problems that its prevalence increase incredibly in the last three decades in KSA. Thirty obese males aged 20 to 39 years will participate in the study. The participants will be evaluated on skinfold thickness, percent of body fat, lipid profile, and exercise capacity. All participants will perform a circuit training of aerobic and resistance exercises and be instructed to follow a low carbohydrate diet for eight weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

3.7 years

First QC Date

March 5, 2021

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • Cardiometabolic index

    High-density lipoprotein, low-density lipoprotein, triglycerides, and total cholesterol will be evaluated through a blood sample from the participants at the start and at the end of 12 weeks of intervention.

    12 weeks

  • Exercise capacity

    The renowned modified sub-maximal treadmill exercise test,which is the leading indicator of EC,was done to calculate maximum oxygen uptake (VO2max). The test began with a warm-up at a speed of 2.7 km/h for five minutes, andthe speed was increasedevery three minutes until the participantexerted the maximum effort and stopped upon exhaustion.

    12 weeks

  • Body Weight

    Measured in kilograms

    12 weeks

  • Height

    Measured in meters

    12 weeks

  • Body mass index

    Measured in kg/m\^2

    12 weeks

  • Waist circumference

    Measured in centimeters

    12 weeks

  • Hip circumference

    Measured in centimeters

    12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The participants will receive circuit training exercise and dietary intervention.

Other: Circuit training exerciseDietary Supplement: Healthy high Fiber diet

Control group

ACTIVE COMPARATOR

The participants will be only involved in dietary intervention.

Dietary Supplement: Healthy high Fiber diet

Interventions

circuit training exercise start with 5 minutes of warming-up then followed by a 30-minute conditioning protocol formed 20 minutes of aerobic exercise and 10 minutes of resisted exercise. The cool-down period is doing in form of walking on a treadmill in low intensity for 5 minutes. Aerobic exercise will be performed on an electronically-braked cycle ergometer (Quinton Excalibur, QuintonInstrument Company, Bothell, WA). resistance exercise (RT) in the form of eight different exercises will be performed during each workout: military press, leg extension, bench press, standing leg curl (ankle weights), lateral pull-down, dumbbell triceps push-down, dumbbell seated biceps curl, and sit-ups (abdominal curls). The participant will do 10 minutes for Aerobic exercise followed by 10 minutes of resistance exercise then 10 minutes for Aerobic exercise. This cycle training will perform five days per week for eight weeks.

Experimental Group
Healthy high Fiber dietDIETARY_SUPPLEMENT

The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.

Control groupExperimental Group

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese young male subjects with a mass index between BMI \>30 kg/m2 and 40 kg/m2).
  • Subjects ages range from 20 to 39 years.
  • Previously sedentary, defined as no strength training and less than 150 minutes of brisk walking or moderate exercise per week and \< less than 60 minutes of vigorous exercise per week in the preceding 6 months.
  • Only subjects who are nonsmokers.
  • Subjects who are not taking insulin.
  • Had no evidence or history of coronary artery disease.

You may not qualify if:

  • Subjects were excluded if they reported a history of heart disease, respiratory conditions, stroke, diabetes, recent cancer, other life-threatening illness, or any condition that limited their ability to engage in moderate-intensity exercise.
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Majmaah University

Majmaah, Riyadh Region, 11952, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Seventy young males with obesity participated in this study. They were divided randomly into two groups. Group 1 received circuit training with low-carbohydrate (LC) diet intervention and Group 2 was the control group. The study variables such as exercise capacity, body composition, skinfold thickness, percentage of body fat (BF%), and lipid profile were measured at the baseline and at the end of a 12-week intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 12, 2021

Study Start

April 11, 2017

Primary Completion

December 20, 2020

Study Completion

December 25, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The Data will be available when the article gets published in a journal.

Locations