This study is a clinical trial. The objective of this study is to investigate the effect of moderate aerobic exercise with caffeine supplementation on central body fat reduction. Thirty women with body mass index ≥25 and 30 >, who do not have diseases that affecting physical activity, heart rate or nutrition status will be recruited.
Design
A randomised trial with a control group, superiority, parallel group trial with blinded participants and outcome assessor.
Settings and conduct
The trial will be run in the Emam Khomeini Hospital.
Aerobic exercise in moderate intensity will be prescribed according to results of treadmill test and heart rate calculation. The participants will be requested to do 30-minutes aerobic exercise including brisk walking or running on treadmill 3-5 days per week for 6 weeks.
Body composition, waist circumference, abdominal and supra-iliac skin folds will be measured and compared before and after the intervention.
The participants and outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Female sex; without pregnancy or regular physical activity or cigarette smoking; without any diseases that affect the heart rate, diet or physical activity; without significant weight reduction over the past 6 months
Exclusion criteria:
Pregnancy during the trial; refuse participation in the trial
Intervention groups
All of the participants will receive caffeine (100 mg) or placebo tablets two times per day, for 6 weeks. All of the subjects will be requested to do aerobic exercise 30 min, 3 to 5 days per week.
Main outcome variables
Waist circumference; abdominal and supra-iliac skin fold; body composition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111025007903N11
Registration date:2019-03-06, 1397/12/15
Registration timing:registered_while_recruiting
Last update:2019-03-06, 1397/12/15
Update count:0
Registration date
2019-03-06, 1397/12/15
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6 Weeks Caffeine Supplementation with Aerobic Exercise on Central Body Fat in Overweight Women.
Public title
Caffeine and central fat reduction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female sex
Without pregnancy or regular physical activity or cigarette smoking
Without any diseases that affect the heart rate, diet or physical activity
Without significant weight reduction over the past 6 months
Exclusion criteria:
Pregnancy during trial
Refuse participation in the trial
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We use simple randomization. Each person takes her own number. Each number is allocated in the control or intervention group according to a table of random numbers. The allocation concealment will be done by the third person who does not contribute to the other process of the trial.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, investigator and data analyser will be blind. A co-worker who not participate in the other trial sections will deliver the caffeine tablets or placebo to the participants according to a randomization table.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
The Center of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.314
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Central fat reduction
Timepoint
Baseline and 6 weeks later
Method of measurement
Waist circumference and local skin fold measurement
Secondary outcomes
1
Description
Body composition
Timepoint
Baseline and 6 weeks later
Method of measurement
Body analyzer device (4Compartment body composition analyzer AVIS33)
Intervention groups
1
Description
Intervention group: The intervention group uses 100 mg caffeine tablets (API production.co) 2 times per day (morning and evening). They do aerobic exercise including brisk walking or running on the treadmill, 3-5 days per week for 6 weeks.
Category
Prevention
2
Description
Control group: The control group uses placebo tablets (Exir production.co), 2 times per day (morning and evening). They do aerobic exercise including brisk walking or running on the treadmill, 3-5 days per week for 6 weeks.