NCT04950062

Brief Summary

The purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 12, 2021

Last Update Submit

June 30, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing the change in Vo2max

    Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.

    Baseline and 2 months post-intervention

  • Assessing the change in body weight

    Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).

    Baseline and 2 months post-intervention

  • Assessing the change in waist hip circumference

    Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio

    Baseline and 2 months post-intervention

Study Arms (2)

High intensity interval training

EXPERIMENTAL

Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.

Other: High Intensity Interval Training

Intermittent fasting

ACTIVE COMPARATOR

Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.

Other: Intermittent Fasting 16/8 Protocol

Interventions

1. Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax). 2. Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax. 3. Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit.

High intensity interval training

Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.

Intermittent fasting

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects have to meet all the following criteria in order to participate in the study:
  • Overweight subjects with age from 25 to 35 years.
  • Body mass index will be range from 25 to 29.9 kg/m2.
  • Waist circumference ≥ 80 cm2.
  • A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.

You may not qualify if:

  • Subjects with the following disorders will be excluded from participating in this study:
  • Musculoskeletal, cardiovascular disorders.
  • Asthma, chronic obstructive pulmonary diseases.
  • Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
  • History of stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Horus University

Damietta, 34518, Egypt

Location

MeSH Terms

Conditions

Overweight

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition 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 Officials

  • Manar Elbaz, Demonstrator

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2021

First Posted

July 6, 2021

Study Start

February 1, 2021

Primary Completion

June 15, 2021

Study Completion

June 30, 2021

Last Updated

July 6, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations