Home » Trials » SLCTR/2021/011
Randomized placebo-controlled trial to determine the effect of a standardized Cinnamon extract on serum cholesterol levels
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SLCTR Registration Number
SLCTR/2021/011
Date of Registration
The date of last modification
Jun 24, 2022
Scientific Title of Trial
Randomized placebo-controlled trial to determine the effect of a standardized Cinnamon extract on serum cholesterol levels
Public Title of Trial
Randomized, double blinded placebo-controlled trial to determine the effect of Cinnamon extract on serum cholesterol levels in people with serum LDL level between 100 mg/dL – 190 mg/dL (100 mg/dL<LDL<190 mg/dL).
Disease or Health Condition(s) Studied
Serum LDL level between 100 mg/dL – 190 mg/dL (100 mg/dL<LDL<190 mg/dL)
Scientific Acronym
N/A
Public Acronym
N/A
Brief title
N/A
Universal Trial Number
U1111-1260-3527
Any other number(s) assigned to the trial and issuing authority
P/131/10/2020 (Faculty of Medicines, UoK)
What is the research question being addressed?
What are the potential effects of daily supplementation of capsules containing Cinnamomum zeylanicum extract on serum cholesterol levels in individuals with average serum LDL level between 100-190 mg/dL (100 mg/dL<LDL<190 mg/dL)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The study will be a randomized, double-blinded, placebo-controlled clinical trial. It will be conducted at the Sri Jayewardenepura General Hospital, Sri Lanka for a period of 3 months, assessing the effects of the daily supplementation of capsules containing C. zeylanicum on individuals with average serum LDL level between 100-190 mg/dL (100 mg/dL<LDL<190 mg/dL)
Eligible participants will be randomized to two different groups.
The participants will be allocated to either cinnamon intervention or placebo group with an allocation ratio of 1:1 using random allocation sequence generated by the R software ‘blockrand’ package. The investigators and participants will remain blinded to treatment allocation until the outcomes are analysed.
The intervention group will receive capsules containing 500mg of powdered ethanol extract (with minimum of 15% proanthocyanidins (PAC A) of cinnamon bark)). Each participant will be instructed to consume one capsule (500 mg) before breakfast and one capsule (500 mg) before dinner daily (1000 mg/daily) for 12 weeks.
The control group will receive the placebo (Wheat flour -white colour tasteless odourless fine powder-1000 mg/daily). Each subject will be instructed to consume one capsules (500 mg) before breakfast and one capsule (500 mg) before dinner daily for 12 weeks.
Inclusion criteria
Exclusion criteria
• Participants with an allergy to cinnamon • Already on cinnamon or any other nutritional / herbal / ayurvedic supplements. • Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years • Any form of malignancy at present or in the past • Blood dyscrasias • Estimated Glomerular Filtration Rate (eGFR) <30ml/min • Patients with diagnosed alcoholic liver disease (ALD), decompensated cirrhosis or abnormal baseline liver function tests (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) - Above three times the upper limit of normal) • Patients with cardiac, liver, renal or respiratory failure • Patients with Atherosclerotic Cardiovascular Disease (ASCVD) or any other major critical illnesses. - This may include any illness, which is certified by the investigator to be a serious illness. For example a. Chronic lung disease b. Severe psychiatric or mental illness c. Severe blood disorders • Any condition that, in the opinion of the primary investigator, would contraindicate the patient’s participation. • Currently on statins or any other lipid lowering drug or if investigator decides that the participant is in need of an immediate lipid lowering therapy (statin) based on clinical judgement. • Participant with triglycerides level >300 mg/dL
Primary outcome(s)
1.
Change in low density lipo-protein (LDL) levels from baseline to final follow-up at three months post randomization. |
[ end of 3 months ] |
Secondary outcome(s)
1.
Changes in other lipid profile parameters (HDL, total cholesterol and triglycerides) from baseline to end of study visit |
[ At the end of 3 months from initiating the intervention ] |
2.
Changes in Fasting Blood Sugar (FBS) and HbA1c from baseline to end of study visit |
[ At the end of 3 months from initiating the intervention ] |
3.
Changes in anthropometric parameters [Weight, waist circumference, hip circumference, and mid arm circumference] from baseline to end of study visit |
[ At each monthly follow up visit ] |
4.
Change in systolic blood pressure and diastolic blood pressure from baseline to end of study visit. |
[ At each monthly follow up visit ] |
5.
Potential effects of regular administration of C. zeylanicum extracts on liver and kidney function \ from baseline to end of study visit. Liver profile tests include Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP). Renal profile tests include Serum creatinine, albumin creatinine ratio (ACR), Glomerular Filtration Rate (eGFR), electrolytes-Na, K, Cl |
[ At each monthly follow up visit ] |
6.
Self-reported side effects in participants of the study from baseline to end of study visit. |
[ At each monthly follow up visit ] |
Target number/sample size
150 (75 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-04-19
Anticipated end date
2021-08-05
Date of first enrollment
2021-05-28
Date of study completion
Recruitment status
Recruiting
Funding source
SDS Spices (PVT) LTD, 17 Horton Pl, Colombo 00700
Regulatory approvals
Pending
Status
Approved
Date of Approval
2021-02-09
Approval number
P/131/10/2020
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka |
Telephone: | 0112961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Dimuthu Muthukuda
Consultant Endocrinologist
Sri Jayawardenapura General Hospital - Nugegoda
0714872935
dimuthutm@yahoo.com
Contact Person for Public Queries
Dr Dimuthu Muthukuda
Consultant Endocrinologist
Sri Jayawardenapura General Hospital - Nugegoda
0714872935
dimuthutm@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results