IRCT | The Effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Antioxidant Indices, Inflammatory Factor, and Liver Enzymes in Patients with Type 2 Diabetes: A Double-Blind Randomized Clinical Trial

#	Registration date	Revision Id
3	2024-01-06, 1402/10/16	291360
2	2023-08-09, 1402/05/18	276883
1	2022-10-10, 1401/07/18	242519

Protocol summary

Study aim: The Co-supplementation of Curcumin and Amla on lipids, Glycemic status, Inflammatory factor, Antioxidant indices, and liver enzymes in Patients with DM2
Design: parallel, double-blind ، randomized.
Settings and conduct: Participants with type 2 diabetes are referred to the diabetes clinic of Bushehr University of Medical Sciences, and will be diagnosed by an endocrinologist. they will be divided into two groups of 25 patients receiving Curcumin +Amla and placebo supplementation. patients receiving Curcumin and Amla 2 capsules daily 500 mg (250mg Curcumin +250mg Amla) and patients in the placebo group also take 2 capsules that are similar in appearance to intervention supplements half an hour after the main meal for 12 weeks. Cans containing capsules and how to use them were coded by a non-researcher as allocation concealment for lack of observing the type of received capsule information.
Participants/Inclusion and exclusion criteria: Inclusion criteria (1 year history of diabetes, age 25 to 65 , BMI 25 and 34.9, taking blood sugar oral medications, informed consent. Exclusion criteria;, (suffering from chronic diseases (liver, kidney, heart, thyroid, rheumatic, pulmonary, metabolic, digestive, malignancies, allergies) pregnancy, breastfeeding, insulin treatment and... etc.)
Intervention groups: Patients are randomly divided into two groups of 25 patients receiving curcumin and Amla and placebo supplementation. In this study, patients are given the supplements for 12 weeks, half an hour after the main meal.. Patients who received 2 capsules of curcumin and Amla (250mg curcumin +250mg Amla) and patients who are in the group receiving placebo (wheat flour) 2capsules daily500 mg, which are similar in appearance to intervention supplements.
Main outcome variables: Lipid profile, Glycemic indices, Antioxidant indices, Inflammatory factor, and liver enzymes

General information

Reason for update: the anthropometry measurement of BMI as secondary outcome has been requested for updating
Acronym
IRCT registration information: IRCT registration number: IRCT20220902055853N1

Registration date: 2022-10-10, 1401/07/18

Registration timing: prospective

Last update: 2023-08-28, 1402/06/06

Update count: 2
Registration date: 2022-10-10, 1401/07/18

Registrant information: Name

fatemeh borazjani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 61 3321 9570

Email address

fa.borazjani@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-10-23, 1401/08/01
Expected recruitment end date: 2023-04-21, 1402/02/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The Effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Antioxidant Indices, Inflammatory Factor, and Liver Enzymes in Patients with Type 2 Diabetes: A Double-Blind Randomized Clinical Trial

Public title: Effect of Co-supplementation of Curcumin and Amla in Patients with Type 2 Diabetes
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Individuals who are diagnosed with T2DM for at least one years ago Age range from 25 to 65 years BMI range between 25 to 34.9 kg/m2 Taking oral blood sugar lowering drugs to control diabetes Consent to participate in the study

Exclusion criteria:

Having chronic diseases (liver, kidney, heart, thyroid, rheumatic, pulmonary, metabolic, digestive, malignancies, allergies) Pregnancy lactation Insulin treatment Taking food supplement, vitamin and mineral for at least in the last 3 months Taking other medicinal plants routinely for at least in the last 3 months Having a weight loss diet for at least in the last6 months Smoking Taking drugs or alcohol in the last 6 months Taking steroid anti-inflammatory drugs and fiber supplements Participate in another trial at the same time
Age: From 25 years old to 65 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization is done individually. The entry of each patient into the Intervention or Control group is distributed in each group using the Randomization method with the help of four blocks. This work is done by using a sequence of random numbers generated by Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists

Blinding (investigator's opinion)

Double blinded

Blinding description

The study will be double-blinded, hence the researcher and participants will not know which group they belong to. For blinding, intervention and placebo capsules are provided in similar shapes, colors, and sizes. These capsules are coded by a person other than the investigators (A and B) and then the capsules are given to participants. Until the end of the study and after analyzing the data, investigators will not know about the intervention and control groups.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethic committee of Ahvaz Jundishapur university of medical sciences,Ahvaz,Iran.

Street address

Academic City - Ahvaz - University of Medical Sciences and Health Care Services Ahvaz - Research and Technology Development Deputy Building - Nutrition and Metabolic Diseases Research Center

City

Ahvaz

Province

Khouzestan

Postal code

6135715794
Approval date: 2022-08-13, 1401/05/22
Ethics committee reference number: IR.AJUMS.REC.1401.196

Health conditions studied

1

Description of health condition studied: Type 2 diabetes
ICD-10 code: E08
ICD-10 code description: Diabetes mellitus due to underlying condition

Primary outcomes

1

Description: Fasting blood glucose
Timepoint: At the beginning and end of study
Method of measurement: Serum sample

2

Description: Hemoglobin A1c
Timepoint: At the beginning and end of study
Method of measurement: Serum sample

3

Description: Fasting Insulin
Timepoint: At the beginning and end of study
Method of measurement: Serum sample

4

Description: hs Crp
Timepoint: At the beginning and end of study
Method of measurement: Sample serum

5

Description: Insulin Sensitivity
Timepoint: At the beginning and end of study
Method of measurement: Formula based

6

Description: Insulin resistance
Timepoint: Aat the beginning and end of study
Method of measurement: Formula based

Secondary outcomes

1

Description: Systolic and Diastolic Blood Pressure
Timepoint: At the beginning,and end of the study
Method of measurement: mercury sphygmomanometer

2

Description: Dietary intake (Energy, Carbohydrate, Fat, Protein)
Timepoint: At the beginning, and end of the study
Method of measurement: Using Nutritionist IV software

3

Description: Physical Activity
Timepoint: At the beginning,and end of the study
Method of measurement: Short form of the International Physical Activity Questionnaire (IPAQ-SF)

4

Description: Health-related Quality of life
Timepoint: At the beginning, and end of the study
Method of measurement: SF-12 questionnaire

5

Description: Serum triglyceride
Timepoint: At the begin and end of study
Method of measurement: Serum sample

6

Description: Total cholesterol
Timepoint: At the begin and end of study
Method of measurement: Serum sample

7

Description: Serum Low Density lipoprotein -Cholesterol (LDL-C)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

8

Description: Serum high Density lipoprotein -Cholesterol (HDL-C)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

9

Description: Malondialdehyde (MDA
Timepoint: At the begin and end of study
Method of measurement: Serum sample

10

Description: Total Antioxidant Capacity (TAC)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

11

Description: Superoxide dismutase (SOD)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

12

Description: Aspartate Transaminase (AST)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

13

Description: Alanine Transaminase (ALT)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

14

Description: Gamma-Glutamyl Transferase (GGT)
Timepoint: At the begin and end of study
Method of measurement: Serum sample

15

Description: body mass index
Timepoint: At the begin and end of study
Method of measurement: Height and weight measurement with scale with the accuracy of 0.1and apply it in the BMI formula

Intervention groups

1

Description: Intervention group: Co-supplementation of Curcumin + Amla (curcumin 250 mg and Amla 250 mg, 2 capsules of 500 mg daily) half an hour after main meals for period of 12 weeks
Category: Treatment - Drugs

2

Description: Control group: Daily 2 capsules of 500 mg containing roasted rice powder as placebo half an hour after main meals for 12 weeks.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Diabetes Clinic of Bushehr University of Medical Sciences

Full name of responsible person

Maryam Behrouzi

Street address

Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran

City

Ahvaz

Province

Khouzestan

Postal code

6135815751

Phone

+98 917 022 9874

Email

mbehroozi474@gmail.com

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Dr. Mehrnoosh Zakerkish

Street address

Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology Address: Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran

City

Ahvaz

Province

Khouzestan

Postal code

6135715794

Phone

+98 61 3336 2414

Email

itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Ahvaz University of Medical Sciences
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: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Maryam Behrouzi

Position

MSc Sstudent

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran

City

Ahvaz

Province

Khouzestan

Postal code

6135815751

Phone

+98 77 3344 6968

Email

mbehroozi474@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Fatemeh Borazjani

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Golestan Boulevard- Golestan- department of nutrition-Jundishapur university of Medical Sciences-Ahvaz-Iran

City

Ahvaz

Province

Khouzestan

Postal code

6135715794

Phone

+98 61 3311 2665

Email

fa.borazjani@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Maryam Behrouzi

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Naval Base, Navy Martyrs Street, Bushehr

City

Bushehr

Province

Boushehr

Postal code

7518614146

Phone

+98 77 3344 6968

Email

mbehroozi474@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: No - There is not 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: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: The effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Inflammatory factor, Antioxidant indices, and liver enzymes in patients with type 2 diabetes: A Double-Blind Randomized clinical trial
When the data will become available and for how long: After the publication of the article
To whom data/document is available: All
Under which criteria data/document could be used: study
From where data/document is obtainable: Fatemeh Borazjani
What processes are involved for a request to access data/document: E mail
Comments

The Effect of Co-supplementation of Curcumin and Amla on lipid profile, Glycemic status, Antioxidant Indices, Inflammatory Factor, and Liver Enzymes in Patients with Type 2 Diabetes: A Double-Blind Randomized Clinical Trial

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