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Investigating the effect of royal jelly supplement in non-alcoholic fatty liver disease

Investigating the effect of royal jelly supplementation on blood lipids, liver enzymes, insulin resistance and inflammatory factors in patients with non-alcoholic fatty liver disease: a double-blind randomized clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110510006431N7
Enrollment
46
Registered
2023-11-19
Start date
2023-11-06
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

This study is a randomized, double-blind, placebo-controlled trial for 8 weeks. The participants are randomly assigned to the royal jelly or placebo arm (23 people in each group) without knowing about

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years diagnosis of NAFLD using ultrasound imaging Body mass index (BMI) 25 and above fasting blood sugar less than 126 no history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men

Exclusion criteria

Exclusion criteria: Smoking history of liver, cardiovascular, pulmonary, kidney disease, celiac disease use of lipid-lowering drugs regular exercise six months before the study basic diet changes weight change of more than 5% in 3 months before screening History of gastric surgeries for weight loss patients using dietary supplements containing n-3 or n-6 fatty acids, vitamin D, E and other antioxidants or fiber supplements in the 12 weeks before the start of the study history of thyroid problems non-compliance Principles of the study protocol

Design outcomes

Primary

MeasureTime frame
TG?Total Cholestrol ? LDL ? HDL C ?ALT? AST ?GGT ? TNF a ? CRP. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: 5 cc of blood is taken to measure the concentration of liver enzymes, lipid profile, inflammatory factors and it is measured by enzymatic methods and using a kit.

Secondary

MeasureTime frame
Weight, body mass index (BMI), waist circumference, hip circumference, ratio of waist circumference to hip circumference, serum glucose, serum insulin, insulin resistance (HOMA-IR), quantitative insulin sensitivity index (QUICKI). Timepoint: At the beginning of the study and after 8 weeks after the intervention. Method of measurement: Taking blood samples using laboratory methods, the weight of each patient is measured with a scale with an accuracy of 100 grams, and the height of each patient without shoes is measured with a height meter with an accuracy of 0.5 cm. The body mass index (BMI) of the patients is calculated, the patient's waist and hips are measured using a tape measure with an accuracy of 0.5 cm, and finally, the body fat percentage of the patients is measured with an in-body device.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfateme hasannia

Shahid Beheshti University of Medical Sciences

hasannia.fatemeh76@gmail.com+98 21 8804 2491

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026