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The Effect of Cydonia oblonga sauce on Obesity and Lipid Profile in Hyperlipidemic Patients Suffering From Obesity and Overweight: A Randomized Clinical Trial

Protocol summary

Study aim
Determination of the effect of quince paste consumption on obesity and lipid profile in hyperlipidemic patients with overweight and obesity
Design
Single-blind, parallel-group randomized controlled trial with block randomization
Settings and conduct
Following initial screening based on inclusion/exclusion criteria and confirmation of no indication for pharmacological therapy according to 10‑year and lifetime atherosclerotic cardiovascular disease risk, informed consent is obtained. Demographic questionnaires, the International Physical Activity Questionnaire (IPAQ), and 3‑day dietary recalls are completed at baseline and study end. Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, and waist‑to‑hip ratio) are performed. At each follow‑up, a medication‑related adverse effects questionnaire is completed, and health indicators are documented via clinical examination and, when indicated, paraclinical tests.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Non-menopausal women and men; hyperlipidemia (total cholesterol exceeding 200 and triglycerides exceeding 200 milligrams per deciliter); age 20–55 years; body mass index 25–39.9 Kilograms per square meter. Exclusion Criteria: Pregnancy; lactation; secondary hyperlipidemia; familial hyperlipidemia; hypertension; diabetes or prediabetes; premature family history of cardiovascular disease; triglycerides exceeding400 milligrams per deciliter or LDL-C exceeding190 milligrams per deciliter; indication for lipid-lowering therapy based on lipid profile and 10-year cardiovascular risk; ; allergy
Intervention groups
Control: lifestyle modification; Intervention: lifestyle modification adjunct to quince sauce
Main outcome variables
obesity, and overweight، Blood lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260504069255N1
Registration date: 2026-08-28, 1405/06/06
Registration timing: prospective

Last update: 2026-08-28, 1405/06/06
Update count: 0
Registration date
2026-08-28, 1405/06/06
Registrant information
Name
soraiya mehryari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 8518
Email address
s.mehryari@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-11, 1405/06/20
Expected recruitment end date
2027-03-11, 1405/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cydonia oblonga sauce on Obesity and Lipid Profile in Hyperlipidemic Patients Suffering From Obesity and Overweight: A Randomized Clinical Trial
Public title
The Effect of Cydonia oblonga sauce on Obesity and Lipid Profile in Hyperlipidemic Patients Suffering From Obesity and Overweight: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and Non-monopausal Women Hyperlipidemia : TG>200mg/dl , TC>200 mg/dl Age range 20-55 years BMI=25 -39.9Kg/m2 Willingness to participate in the study
Exclusion criteria:
Pregnancy, breastfeeding, menopause, oophorectomy, PCOS Bone, rheumatoid, thyroid, parathyroid, cardiac, hepatic, pulmonary, renal, intestinal diseases, malignancies, and fever Familial hyperlipidemia High blood pressure Family history of premature cardiovascular disease Diabetes and Prediabetes LDL>190mg/dl, TG>400mg/d The need to initiate lipid-lowering therapy based on lipid levels and ASCVD criteria (10-year cardiovascular disease risk). Obtaining hyperlipidemia medications Presence of symptoms of an infectious, inflammatory, or surgical condition within the last three months. Use of insulin, glibenclamide, corticosteroids, or estrogen. vitamin/mineral supplementation, weight‑loss drugs, or diet/exercise program within 3 months prior to or during the study. Tobacco, cigarettes, alcohol, or drugs allergy to quince or its products (e.g., sauce, jam), or quince consumption within the past 3 months."
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
They will be randomly assigned to two equal groups (30 participants per group): the control group will receive lifestyle modification, and the intervention group will receive lifestyle modification plus quince paste.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a single‑blind (assessor‑blinded) trial, wherein the anthropometrics and the laboratory analyst will remain unaware of the group allocation (intervention versus control).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee, Tabriz University of Medical Sciences, 29 Bahman Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2026-07-22, 1405/04/31
Ethics committee reference number
IR.TBZMED.REC.1405.242

Health conditions studied

1

Description of health condition studied
High blood lipids
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified

2

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

Primary outcomes

1

Description
Obesity and Overweight
Timepoint
Start of the study and end of the study (two months later)
Method of measurement
Measurement of BMI, waist circumference, and hip circumference.

Secondary outcomes

1

Description
Blood lipid profile
Timepoint
At the beginning and end of the study (two months later)
Method of measurement
Fasting venous blood samples will be obtained for the measurement of total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C). Low-density lipoprotein cholesterol (LDL-C) levels will then be calculated using the Friedewald formula: LDL-C = TC – HDL-C – (TG / 5) provided TG < 400 mg/dL

2

Description
Cydonia oblonga sauce Side effects
Timepoint
At the beginning and end of the study (two months later)
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Intervention group: 5 grams of the paste (using the provided scoop), three times daily, half an hour before meals, In addition to lifestyle measures
Category
Treatment - Other

2

Description
Control group: lifestyle measures
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sinai Hospital
Full name of responsible person
Dr Soraiya Mehryari
Street address
Azadi Street, between Hafez and Montazeri Intersections, Sina Educational, Research, and Treatment Center
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2151
Email
info@sinahosp.tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Soraiya Mehryari
Street address
Next to the university
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
Email
imamreza@tbzmed.ac.ir

3

Recruitment center
Name of recruitment center
Sheikh-ol-Raees Clinic
Full name of responsible person
dr Soraiya Mehryari
Street address
Azadi Street, just before Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5165638464
Phone
+98 41 3336 6215
Email
www.dabirkhanecent@tbzmed.ac.ir

4

Recruitment center
Name of recruitment center
Tabriz City Health Center 1
Full name of responsible person
dr Soraiya Mehryari
Street address
Jihad Square (Nesf-e Rah)
City
Tabriz
Province
East Azarbaijan
Postal code
5183875357
Phone
+98 41 3444 9184
Email
eazphc@tbzmed.ac.ir

5

Recruitment center
Name of recruitment center
Tabriz City Health Center 2
Full name of responsible person
dr Soraiya Mehryari
Street address
Tabriz County Health Center, Molla Sadra Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165994622
Phone
+98 41 3177 4351
Email
eazphc@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adib kia
Street address
Golgasht Street – Central Building No. 2 – Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 7310 3335
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Soraya Mehryari
Position
Iranian Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3337 9528
Email
s.mehryari@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Bagherzadeha Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tabriz University of Medical Sciences, School of Traditional Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3337 9528
Email
Bagerzadeha@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Soraya Mehryari
Position
Iranian Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3337 9528
Fax
Email
s.mehryari@tbzmed.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 further information is available.
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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