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

19 Apr 2021

The date of last modification

Apr 22, 2021



Application Summary


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)


Trial Details


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

  • Age between 18-70 years
  • Both male and female
  • LDL level; between 100 and 190 mg/dL (100 mg/dL < LDL < 190mg/dL)

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


Date of study completion


Recruitment status

Pending


Funding source

SDS Spices (PVT) LTD, 17 Horton Pl, Colombo 00700


Regulatory approvals

Pending



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

SDS Spices (PVT) LTD

SDS Spices (PVT) LTD, 17 Horton Pl, Colombo 00700
0112688913


Secondary study sponsor (If any)







Trial Completion details


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