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The Effect of Selected training and Nano-Curcumin Supplementation on some Blood Factorsin Patients after Bariatric Surgery

Protocol summary

Study aim
The Effect of Selected Training and Nano-Curcumin Supplementation on LDL, HDL, Triglycerides, Body Fat Percentage, Ferritin, Albumin, Hemoglobin, ALT, and AST Levels in Post-Bariatric Surgery Patients
Design
Study Design: A phase 2, randomized, parallel-group, single-blind clinical trial conducted on 80 post-bariatric surgery patients aged 30-45 years. Randomization will be performed using the RAND function in Excel software.
Settings and conduct
The research will be conducted at the Tehran Minimally Invasive Surgery Research Center using a semi-experimental pretest-posttest control group design
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Obese men and women (BMI thirty or higher) aged thirty to forty-five years with no unstable hemodynamic conditions or mobility disorders and no underlying medical conditions including advanced pulmonary or kidney diseases liver cirrhosis hepatitis or gastrointestinal disorders such as celiac disease or diverticulosis who do not use medications tobacco or alcohol and have completed the PAR-Q questionnaire Exclusion Criteria:Allergy to nano-curcumin or related plant species reoperation cases use of alcohol or specified medications including metformin levothyroxine cortisone or topiramate within one month prior to study unwillingness to continue participation missing more than three training sessions or more than two nano-curcumin doses any health risks identified by physician during study protocol
Intervention groups
Training group Nanocurcumin consumption group Training + Nanocurcumin consumption group Control group
Main outcome variables
The study will measure LDL HDL triglycerides body fat percentage ferritin albumin hemoglobin ALT and AST levels.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250420065394N1
Registration date: 2025-04-28, 1404/02/08
Registration timing: prospective

Last update: 2025-04-28, 1404/02/08
Update count: 0
Registration date
2025-04-28, 1404/02/08
Registrant information
Name
Mohammadreza Goshtasbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 8815
Email address
goshtasbimohammadreza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Selected training and Nano-Curcumin Supplementation on some Blood Factorsin Patients after Bariatric Surgery
Public title
The Effect of Selected training and Nano-Curcumin Supplementation on some Blood Factorsin Patients after Bariatric Surgery
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Obese men and women (BMI ≥30) Absence of medically unstable hemodynamic conditions Absence of movement disorders No underlying conditions such as advanced pulmonary/kidney diseases, liver cirrhosis, hepatitis, or gastrointestinal disorders (e.g., celiac disease, diverticulosis) No use of medications, tobacco, alcohol, or supplements Completing the PRQ form for more accurate assessment of physical health in individuals
Exclusion criteria:
Individuals allergic to nano-curcumin or other plants of the Zingiberaceae family Second surgery Use of alcohol and medications (metformin, levothyroxine, cortisone, and topiramate) within 1 month prior to the study Unwillingness to continue participation in the study Absence from more than three research sessions or failure to take nano-curcumin capsules more than twice Occurrence of any health risks or complications for patients during the study protocol implementation, as confirmed by the attending physician Age Range:30-45 years
Age
From 30 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- East Tehran Branch
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.IAU.ET.REC.1404.003

Health conditions studied

1

Description of health condition studied
Patients after Bariatric Surgery
ICD-10 code
E66.8
ICD-10 code description
Other obesity

Primary outcomes

1

Description
Low-density lipoprotein
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

2

Description
high-density lipoprotein
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

3

Description
Ferritin
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

4

Description
Albumin
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

5

Description
Hemoglobin
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

6

Description
Alanine Aminotransferase
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

7

Description
Aspartate Aminotransferase
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

8

Description
Triglyceride
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Measurements will be performed using standard laboratory kits.

9

Description
body fat percentage
Timepoint
Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
Body fat percentage will be measured using the InBody 570 device.

Secondary outcomes

1

Description
Palatable Food Craving Questionnaire - Trait (PFQ-T)
Timepoint
The questionnaire will be administered at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol.
Method of measurement
The PFQ-T questionnaire will be completed by patients before and after the research protocol, with all resulting data collected.

Intervention groups

1

Description
Intervention Group Protocol:1. Nano-curcumin Supplementation: - Initiation: 1 month post-bariatric surgery - Product: Sina Curcumin brand - Dosage: 40 mg twice daily (with meals) - Tablet specification: Each tablet contains 40 mg nano-curcumin - Duration: 60 days2. Exercise Training: - Frequency: 3 sessions/week - Program duration: 60 days - Session components: - Warm-up - Cool-down - Resistance training - Aerobic exercise - Progressive overload: - Week 1 intensity: 50-60% of maximum heart rate (HRmax) - Final week intensity: 65-70% of HRmax - Weekly increases in both duration and intensity
Category
N/A

2

Description
Intervention Group Protocol:Post-bariatric surgery patients will begin nano-curcumin supplementation (Sina Curcumin brand) at 1-month postoperative, administered as: Dosage: 40 mg twice daily (total 80 mg/day) Formulation: 40 mg tablets (one tablet per dose) Administration: With meals Duration: 60 consecutive days
Category
N/A

3

Description
Exercise Protocol:The selected training program will be performed three times per week for 60 days. Each session will include warm-up, cool-down, resistance training, and aerobic exercises. Training duration and intensity will progressively increase weekly, with intensity rising from 50-60% of maximum heart rate in week 1 to 65-70% of maximum heart rate in the final week.
Category
Rehabilitation

4

Description
Control group: No intervention takes place.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Minimally Invasive Surgery Research Center
Full name of responsible person
Mohammad Reza Goshtasbi
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Phone
+98 912 486 8636
Email
goshtasbimohammadreza@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shokoh Rashvand Samyari
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Phone
+98 912 486 8636
Email
goshtasbimohammadreza@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Goshtasbi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Phone
+98 21 8809 8815
Email
goshtasbimohammadreza@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Goshtasbi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Phone
+98 21 8809 8815
Email
goshtasbimohammadreza@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Goshtasbi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1465896460
Phone
+98 21 8809 8815
Email
goshtasbimohammadreza@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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