The interactive effect of Pilates training and nano-curcumin supplementation on body composition and selected indices of non-alcoholic fatty liver disease in obese and overweight females
The interactive effect of 8 weeks of Pilates training and nanocurcumin supplementation on body composition and selected indicators of non-alcoholic fatty liver in obese and overweight women
Design
Two arm parallel group trial with a blind, Pre-test and post-test, not randomized
Settings and conduct
The current single blind study (blind subject) with a pre-test and post-test design with the presence of a placebo is performed in NAFLD patients referred to the specialized gastro-hepatology clinic in Rasht. The 8-week research protocol includes daily consumption of 80 mg nano-curcumin supplement or placebo and 3 days per week selected aerobic pilates exercises for 1 hour per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with confirmed non-alcoholic fatty liver and and BMI>25, WHR>0.85
Exclusion criteria: suffering from other liver diseases, diabetes, cancer, cardiovascular diseases, thyroid disorders, taking drugs affecting on research variables
Intervention groups
The control group includes exercise-placebo and the intervention group includes exercise-supplement.
Main outcome variables
Body composition, liver enzymes and other selected liver indicators, severity of fatty liver
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220518054903N1
Registration date:2023-03-05, 1401/12/14
Registration timing:retrospective
Last update:2023-03-05, 1401/12/14
Update count:0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
leila rezaei
Name of organization / entity
Faculty of Physical Education and Sports Sciences of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3342 2616
Email address
star_6439@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-21, 1401/05/30
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
2022-08-21, 1401/05/30
Actual recruitment end date
2022-09-01, 1401/06/10
Trial completion date
2022-11-03, 1401/08/12
Scientific title
The interactive effect of Pilates training and nano-curcumin supplementation on body composition and selected indices of non-alcoholic fatty liver disease in obese and overweight females
Public title
Interactive effect of Pilates training and nano-curcumin on fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-alcoholic fatty liver disease patients
being Overweight or obese (WHR>0.85, BMI>25)
Exclusion criteria:
participating in a regular exercise program for the past 6 months
Presence of musculoskeletal injury
sensitivity to turmeric and curcumin
Consumption of dietary supplements in the last 3 months
smoking and alcohol
Taking drugs that lower blood glucose, blood lipids and anti-inflammatory drugs and any drugs that affect liver function
Other liver diseases and diabetes, cancer, cardiovascular disease and thyroid disorders
pregnancy or breastfeeding
Age
From 25 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are divided into two groups, supplement and placebo, and they do not know which one will receive the supplement and which one will receive the placebo.
Nanocurcumin supplement is available in the form of orange jelly capsules. The placebo capsules will be prepared in the same colour. The capsules will be removed from the strips of the manufacturing company and will be given to the participants in the same package as the placebo capsules. In addition, the subjects take the supplements at home and do not see how other people use them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Persian Gulf Highway, km 5 Qazvin Road, Guilan University Complex
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.GUILAN.REC.1401.025
Health conditions studied
1
Description of health condition studied
Non Alcoholic Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
کبد چرب غیر الکلی
Primary outcomes
1
Description
The degree of hepatic steatosis
Timepoint
48 hours before and after the intervention
Method of measurement
Fibroscan machine made in Germany using abdominal elastography method
Secondary outcomes
1
Description
Body fat percentage
Timepoint
48 hours before and after the intervention
Method of measurement
Lafayette caliper made in America with Jackson and Pollock three-point method
2
Description
BODY MASS INDEX
Timepoint
48 hours before and after the intervention
Method of measurement
Height and weight measurement from Seca model 220 scale made in Germany and put in BMI formula
3
Description
visceral fat
Timepoint
48 hours before and after the intervention
Method of measurement
meter reading
4
Description
serum concentration of liver enzymes
Timepoint
48 hours before and after the intervention
Method of measurement
using the Biorex Fars kit, made in Iran and with an auto-analyzer device
5
Description
lipid profile
Timepoint
48 hours before and after the intervention
Method of measurement
using the Biorex Fars kit, made in Iran and with an auto-analyzer device
Intervention groups
1
Description
Intervention group: Pilates-curcumin group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg nanocurcumin capsules produced by Exsir-Nano Sina company.
Category
Treatment - Drugs
2
Description
Control group: Pilates-placebo group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg capsules of corn starch (placebo)