Protocol summary
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Study aim
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To examine the effects of J. sambac consumption in combination with a conventional diet on glycemic indices, lipid profiles, inflammatory activity, platelet aggregation and measures of oxidative stress in NAFLD patients.
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Design
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Pragmatic, community bases, parallel group, double blinded, randomised control trial. 90 patients will be enrolled into 3 groups. Study will be done form March-May 2023
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Settings and conduct
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At Muhammad's physical therapy clinic and rehabilitation center, Multan, Pakistan, 90 suitable persons who had just received a fresh diagnosis of NAFLD (38 men and 52 women) were gathered from outpatient visits
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Participants/Inclusion and exclusion criteria
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Participants in the study were to be 23 to 77 years old, have a body mass index >25 kg/m2, and have diagnosed NAFLD as determined by an ultrasound examination. The following were the exclusion criteria:following a weight reduction diet in the three months earlier, modifying dosage of anti-diabetic, anti-hyperlipidemic, and anti-hypertensive drugs, ingesting just under 70percent of the J. sambacsalad,nicotine, using other drugs, and a past stroke, cardiomyopathy, diabetes, any form of the severe retinal disorder, stomach ulcers, kidney stones, or any additional liver, kidney, lung, or heart disease, among other underlying illness
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Intervention groups
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Before lunch, the 1st group (intervention group) was instructed to eat the conventional diet combined with 200 mg/kg bw/day(12) of J.sambac in the form of salad, while the 2nd group (positive control) received the silymarin with 100mg/kg bw 2 times a day and the 3rd group (negative control) just got the conventional diet. The recommended diet, which included 20% protein, 55% carbohydrate, and 30% fat, supplied around 1500 kcal/day
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Main outcome variables
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Glycemic indices, lipid profiles, inflammatory activity, platelet aggregation and measures of oxidative stress
General information
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Reason for update
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Mistakenly some data have been put which needs correction. Please evaluate and accept
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230424057987N1
Registration date:
2023-04-29, 1402/02/09
Registration timing:
registered_while_recruiting
Last update:
2023-05-10, 1402/02/20
Update count:
1
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Registration date
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2023-04-29, 1402/02/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-05, 1401/12/14
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Expected recruitment end date
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2023-05-05, 1402/02/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Hepatoprotective Effects of Jasminum sambac on Individuals With Non alcoholic Fatty Liver Disease's Metabolic Profiles
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Public title
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Effects of Jasminum sambac on Individuals With Non alcoholic Fatty Liver Disease's Metabolic Profiles
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Participants in the study were to be 23 to 77 years old
Body mass index >25 kg/m2
Participants diagnosed with NAFLD as determined by an ultrasound examination
Exclusion criteria:
Following a weight reduction diet in the three months earlier
Anti-diabetic, anti-hyperlipidemic, and anti-hypertensive drugs
Past stroke
Cardiomyopathy
Diabetes
Retinal disorder
Stomach ulcers
Kidney stones
Using other drugs
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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- Investigator
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Double blinded study i-e randomization of participants in groups by lottery method and statistical analysis without biasness.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Investigator and data analyser will be kept blind to avoid any biasness as this is a double blinded study
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-02-05, 1401/11/16
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Ethics committee reference number
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MIMAS/06/26/I.A.K.DURRANI
Health conditions studied
1
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Description of health condition studied
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Nonalcoholic fatty liver disease
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ICD-10 code
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K76.0
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ICD-10 code description
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Nonalcoholic fatty liver disease
Primary outcomes
1
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Description
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Fasting blood sugar (FBS)
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Timepoint
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3 months
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Method of measurement
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Venous blood samples willbe taken at the start and completion of the trial
2
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Description
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Triglycerides (TG)
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Timepoint
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3 months
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Method of measurement
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Venous blood samples will be taken at the start and completion of the trial and then evaluated using an enzymatic colorimetric assay utilizing commercial kits (Pars Azmoon).
3
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Description
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Total cholesterol (TC), LDL cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
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Timepoint
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3 months
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Method of measurement
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Venous blood samples will be taken at the start and completion of the trial and then evaluated using an enzymatic colorimetric assay utilizing commercial kits (Pars Azmoon). After apolipoprotein B-containing lipoproteins were precipitated using chloride magnesium and dextran sulphate as part of the oxidase cholesterol technique, serum HDL and LDL cholesterol levels were measured.
4
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Description
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ALT(alanine transaminase), AST (aspartate aminotransferase), ALP (alkaline phosphatase) , LDH (lactate dehydrogenase)
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Timepoint
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3 months
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Method of measurement
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Venous blood samples will be taken at the start and completion of the trial
5
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Description
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Total antioxidant capacity
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Timepoint
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3 months
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Method of measurement
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Assessed by using 2,2-diphenyl-1-picrylhydrazyl (DPPH)
6
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Description
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Platelet aggregation and platelet activation.
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Timepoint
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3 months
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Method of measurement
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Platelet aggregation was evaluated using impedance aggregometry, and platelet activation was assessed using flow cytometry.
7
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Description
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Inflammation
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Timepoint
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3 months
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Method of measurement
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Inflammation measured by check the CRP level.
Secondary outcomes
1
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Description
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Systolic (SBP) and diastolic blood pressure(DBP)
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Timepoint
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3 months
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Method of measurement
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Sphygmomanometer
Intervention groups
1
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Description
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Intervention group: 1st group (interventional group) was instructed to eat the conventional diet combined with 200 mg/kg bw/day of J.sambac in the form of salad,
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Category
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Treatment - Other
2
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Description
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Control group: 2nd group (positive control) received the silymarin with 100mg/kg bw 2 times a day
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Category
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Treatment - Other
3
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Description
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Control group: 3rd group (negative control) just got the conventional diet. The recommended diet, which included 20% protein, 55% carbohydrate, and 30% fat, supplied around 1500 kcal/day
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Student fund
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Grant code / Reference number
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26082023
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ali –Ul- Murtaza Department of Rehabilitation Science, MIMAS
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available