Protocol summary

Study aim
Determining and comparing the effect of curcumin supplementation on the dominant intestinal bacterial microbiome and butyrogenic bacteria in obese people under a weight loss diet compared with placebo
Design
Clinical trial with the intervention and control groups, parallel, double blinded, randomized, phase III will perform on 80 participants with overweight and obesity. At the first,participants will randomize based on codes to A and B by the code-holder. codes will decoded after statistical analysis.
Settings and conduct
Obese and overweight people refer to Shafiyeh Zanjan clinic to lose weight
Participants/Inclusion and exclusion criteria
inclusion: Adults aged 18-50 years old, with body mass index equal-higher than 27.5 kg/m2 who refer to the specialized clinic to lose weight, will be selected. un-included: pregnancy or breastfeeding, lack of informed consent to participate in the study, presence of malignancies, chronic liver disease (fatty liver confirmed by ultrasound), renal failure (serum creatinine ≥ 2.0 mg/dl), dialysis), inflammatory diseases. Chronic conditions such as rheumatoid arthritis and acute infections, thyroid disorders (such as hypothyroidism or hyperthyroidism), blood sugar disorders including fasting or two-hour diabetes or other types of diabetes, receiving hormones or other herbal treatments, and allergies to turmeric or any spice, people on a special diet, intake of pro kinetic and anti acid drugs, gastrointestinal disorders. Exclusion: unwillingness to pursue the study. intake of antibiotic in any step of study
Intervention groups
The first group will intake curcumin supplement with the dose of 500 mg and the second group will intake placebo containing 500 mg starch, two times per day, one drug in each time, with the lunch and dinner meals.
Main outcome variables
population of the dominant gut phyla and some butyrogenic bacteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240209060948N1
Registration date: 2024-08-18, 1403/05/28
Registration timing: registered_while_recruiting

Last update: 2024-08-18, 1403/05/28
Update count: 0
Registration date
2024-08-18, 1403/05/28
Registrant information
Name
ROGHyyeh Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3376 2903
Email address
mansouri8801@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin supplementation on the dominant intestinal microbiome and butyrogenic bacteria in obese people under a weight loss diet
Public title
Curcumin and the gut microbiota alterations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male and female between 18-50 yr old body mass index equal-higher than 27.5
Exclusion criteria:
pregnancy and lactation in females any type of diagnosed disease including neoplasm, kidney and liver diseases thyroid disorders metabolic disorders intake of pro-kinetics and antacid drugs mental disorders and depression antibiotic intake probiotic, prebiotic and synbiotic intake intake of foods containing probiotic people under a certain diet gastrointestinal disorders including malabsorptive diseases, constipation and diarrhea
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
More than 1 sample in each individual
Number of samples in each individual: 2
male and female aged 18-50 years old without any diagnosed disease which refereed to the Nutritionist for weight loss and have body mass index equal-higher than 27.5 kg/m2.
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will be used as two groups with 8-number blocks including 5 participants in each group. Randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment.at this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are similar in appearance, color, smell, shape and packaging, and they will receive codes A and B. Participants will also be assigned to the code A, B. The main researcher and the participant are not aware of the arrangment in the groups and will only participate in the study with the assigned codes. Statistical analyzes will also be based on the codes. After ending the study, the codes will be decoded and the results will be reported.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University - Zanjan branch
Street address
Zanjan, Shahrak Andisheh, North Fereshte St., Ferdous corner, 14 Plot 304, 2nd floor
City
Zanjan
Province
Zanjan
Postal code
4514483889
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.IAU.Z.REC.1403.071

Health conditions studied

1

Description of health condition studied
Obesity and weight gain
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
weight loss
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
calibrated scale

2

Description
population of Firmicutes phyla
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
realtime polymerase chain reaction

3

Description
population of Bacteroidetes phyla
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
realtime polymerase chain reaction

4

Description
population of Actinobacteria phyla
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
realtime polymerase chain reaction

5

Description
population of proteobacteria phyla
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
realtime polymerase chain reaction

6

Description
population of butyrogenic bacteria including butyrovibrio, facali prausnitzi, clostridium and roseburia
Timepoint
at the baseline and after two month of intervnetion
Method of measurement
realtime polymerase chain reaction

Secondary outcomes

1

Description
Short chain fatty acids including acetate, propionate, butyrate and valerate.
Timepoint
at the baseline and end of study
Method of measurement
Gas chromatography-Mass spectrometery

Intervention groups

1

Description
Control group: placebo containing 500 mg starch which will consume two-times per day with lunch and dinner meals for 8 weeks. Placebo with the same color, smell and size with the drug will provide from Karen pharma Company, Iran.
Category
Placebo

2

Description
Intervention group: Curcumin containing 500 mg pure curcumin which will consume two-times per day with lunch and dinner meals for 8 weeks. Curcumin supplement will provide form KAren Pharma Company, IRan.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafiyyah clinic, nutrition unit
Full name of responsible person
Ruqiya Mansouri
Street address
2nd floor, plot 304, 14 Ferdous corner, Ferdows corner, Andisheh town, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4514483889
Phone
+98 912 742 8801
Email
mansouri8801@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehdi Bazargani
Street address
Zanjan, Shahrak Andisheh, North Fereshte St., Ferdous corner, 14 Plot 304, 2nd floor
City
Zanjan
Province
Zanjan
Postal code
4514483889
Phone
+98 24 3376 2903
Email
mbzirn@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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Shahid Avval Ave, 3th Shaban St., after Janbazan Square (Honarestan), Khorramshar Blv., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515863994
Phone
+98 24 3377 9244
Email
neda.mousavi@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Neda Mousavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Shahid avval Ave, 3th Shaban St, after Janbazan Square (Honarestan), Khorramshahr Blv, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515863994
Phone
+98 24 3377 2020
Email
neda.mousavi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Neda Mousavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Shahid Avval Ave, 3th Shaban St, after Janbazan square (Honarestan), Khorramshahr Blv, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515863994
Phone
+98 24 3377 2020
Email
neda.mousavi@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
It will be made available to the research and technology vice-chancellor of Islamic Azad University, Zanjan Branch
When the data will become available and for how long
after paper publication
To whom data/document is available
researchers based on the request to the corresponding author of the paper
Under which criteria data/document could be used
for future studies or metaanalysis
From where data/document is obtainable
Islamic Azad University, Zanjan Branch, Arazi Paeen Kooh, Daneshjoo Blv, Zanjan Tel: 024-33469500, postal cod: 45156-58145
What processes are involved for a request to access data/document
request by the electronic e-mail to Mrs. Roqaye Mansouri under the e-mail address mansouri8801@gmail.com
Comments
Loading...