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The effect of Rheum ribes extract supplementation on anthropometric parameters and oxidative stress: randomized, double-blinded clinical trial.

Protocol summary

Study aim
The effect of Rheum ribes extract supplementation on anthropometric parameters and oxidative stress
Design
Clinical trial with a control group, parallel groups, double-blind, and randomized, phase 3 study involving 80 patients. Randomization was conducted using the online site.
Settings and conduct
The study will be conducted at the clinic of 22 Bahman Hospital, and individuals who meet the inclusion criteria in 1402 will be included in the project. Volunteers will be randomly assigned to two groups: those receiving the drug and the placebo group. Before the study, a 10 ml intravenous blood sample will be taken to perform the PAB test. Additionally, anthropometric parameters will be collected, and the intervention will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Persons within the age range of 18 to 60 years old, Individuals with a BMI ranging from 29.9 to 39.9, Absence of autoimmune diseases, cancer, acute or chronic infectious diseases, kidney stones, gallstones, and advanced heart diseases as comorbidities, The absence of any medication or any other herbal supplement aimed at weight reduction that may interfere with the results. exclusion criteria: The patient's dissatisfaction with continuing the study. Irregular medication usage, Any new disease that was not present before the intervention, The use of new medication that may interfere with the study results, Migration, Initiation of a new therapeutic or exercise regimen, and consumption of a new dietary supplement or its prior usage.
Intervention groups
The intervention group comprises recipients who receive 400 milligrams of Rivas extract capsules three times a day for 12 weeks, while the control group comprises recipients who receive placebos three times a day for 3 months.
Main outcome variables
weight; BMI; waist circumference; hip circumference; biceps size; body fat percent; muscle mass; PAB

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240424061561N1
Registration date: 2024-05-29, 1403/03/09
Registration timing: prospective

Last update: 2024-05-29, 1403/03/09
Update count: 0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
pooria etesamizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4333 3515
Email address
etesamizadehp951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-22, 1403/04/02
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rheum ribes extract supplementation on anthropometric parameters and oxidative stress: randomized, double-blinded clinical trial.
Public title
The effect of Rheum ribes on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 18 to 60 years old. Individuals with a body mass index (BMI) between 29.9 and 39.9 Absence of autoimmune diseases, cancer, acute or chronic infectious diseases, kidney stones, gallstones, and advanced heart diseases as comorbidities The absence of any medication or herbal supplement intended for weight reduction that may affect the results
Exclusion criteria:
The patient is dissatisfied with continuing the study Irregular use of medication Any new disease that did not exist before the intervention The use of new medication that may interfere with the study results Migration Initiation a new therapeutic or exercise regimen consumption a new dietary supplement or its prior usage
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
More than 1 sample in each individual
Number of samples in each individual: 40
Intervention group: 40 obese men and women will each receive 3 capsules of 400 mg of rhubarb ethanolic extract daily for 12 weeks. Control group: 40 obese men and women will receive three placebo capsules per day, which are completely similar in appearance and volume to the rhubarb capsules, for 12 weeks.
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will first be categorized based on gender, age, weight, and health status (including blood pressure, diabetes, and blood lipids). Then, they will be randomly assigned to one of two groups using the balanced block method. This ensures that both groups have an even distribution of age, sex, weight, and health status. We will use the online site (www.sealedenvelope.com) to perform the randomization.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To ensure blinding during the randomization process, unique codes generated by the website (www.sealedenvelope.com) will be used on the supplement boxes. Each participant will be assigned medication boxes with specific codes based on the generated sequence, ensuring that no one knows the type of treatment they receive until they are selected.
Placebo
Used
Assignment
Parallel
Other design features
Patients will be sorted based on gender, age, weight, and health status (including blood pressure, diabetes, and blood lipid levels). They will then be divided into two groups using a balanced-block method to ensure an even distribution of age, gender, weight, and health status in each group. The randomization process will be carried out using the online website (www.sealedenvelope.com).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neyshabur University of Medical Science
Street address
Medical science university campus, End of Moghavemat Ave, Neyshabur Town
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318614139
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.NUMS.REC.1403.011

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
before and after the intervention
Method of measurement
Using the Inbody bioimpedance device

2

Description
waist circumference
Timepoint
before and after the intervention
Method of measurement
Inelastic meters

3

Description
hip circumference
Timepoint
before and after the intervention
Method of measurement
Inelastic meters

4

Description
biceps size
Timepoint
before and after the intervention
Method of measurement
Inelastic meters

5

Description
body fat percent
Timepoint
before and after the intervention
Method of measurement
Using the Inbody bioimpedance device

6

Description
muscle mass
Timepoint
before and after the intervention
Method of measurement
Using the Inbody bioimpedance device

7

Description
Pro-oxidant Antioxidant Balance (PAB)
Timepoint
before and after the intervention
Method of measurement
PAB assay

8

Description
Body Mass index
Timepoint
before and after the intervention
Method of measurement
weight/height (2)

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, patients are first sorted based on their gender, age, weight, and health status, including blood pressure, diabetes, and blood lipids. They are then randomly assigned to two groups using a balanced-block method to ensure that the average distribution of age, gender, weight, and health status is similar in each group. The intervention group receives 400-milligram capsules of Rivas extract. According to studies by Ghaffouri and Shad, taking 400 milligrams of Rivas extract three times a day for 12 weeks leads to the most significant weight loss without any adverse effects. The method for producing ethanol extract of Rivas is also based on the study by Ghaffouri and colleagues.
Category
Treatment - Drugs

2

Description
Control group: The participants in the control group are provided with capsules containing starch, which serve as a placebo. These capsules are carefully prepared to match the size, appearance, and smell of the Rivas extract capsules. The placebo supplements are distributed in identical containers to the nutrition specialists. Each container is randomly labeled with proprietary software codes, without indicating the group type. This ensures that the researcher, patient, and physician are unaware of the type of placebo or supplement used in each group. Patients in the control group then undergo treatment with placebo capsules weighing 400 milligrams three times a day for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Pooria Etesamizadeh
Street address
22 Bahman Hospital, in front of Amiran hotel, Imam Khomeini street, Neyshabur
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318614139
Phone
+98 51 4330 4143
Email
info@nums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Seyyed Mostafa Arabi
Street address
Neyshabur medical university, end of Moghavemat Ave, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318614139
Phone
+98 51 4262 7521
Email
edu@nums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Pooria Etesamizadeh
Position
Elite soldier
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No.22, Third Mollasadra, Mollasadra Ave, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9314794576
Phone
+98 51 4333 3515
Email
etesamizadehp951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Pooria Etesamizadeh
Position
Elite soldier
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No.22, Third Mollasadra, Mollasadra Ave, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9314794576
Phone
+98 51 4333 3515
Email
etesamizadehp951@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Pooria Etesamizadeh
Position
Elite soldier
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No.22, Third Mollasadra, Mollasadra Ave, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9314794576
Phone
+98 51 4333 3515
Email
etesamizadehp951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more available information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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