The effects of green cardamom supplementation on blood pressure and endothelium function in type 2 diabetic patients: A study protocol for a randomized controlled clinical trial
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Shohreh Ghazi Zahedi1, Fariba Koohdani2, Mostafa Qorbani3
1Department of Community Nutrition.
Insights
Green cardamom supplementation may improve blood pressure and markers of inflammation and endothelial function in type 2 diabetes patients. This 10-week study investigated cardamom
Area of Science:
- Cardiovascular Health
- Metabolic Disorders
- Nutritional Science
Background:
- Cardamom has known antioxidant and anti-inflammatory properties.
- Limited research exists on cardamom's effects in type 2 diabetes patients.
- Endothelial dysfunction is a concern in type 2 diabetes.
Purpose of the Study:
- To evaluate the impact of 10-week green cardamom intake on blood pressure.
- To assess changes in inflammatory and endothelial function biomarkers.
- To explore potential mechanisms of action in type 2 diabetes mellitus (T2DM) patients.
Main Methods:
- A 10-week randomized controlled trial involving 80 overweight/obese T2DM patients.
- Participants received either 3g/day cardamom or a placebo.
- Measurements included blood pressure, asymmetric dimethylarginine, nitric oxide, and various inflammatory/endothelial markers.
Main Results:
- (Results not yet available as per abstract)
- The study design allows for comprehensive analysis of cardamom's effects.
- Data on blood pressure and biomarker changes will be collected at baseline and study end.
Conclusions:
- (Conclusions not yet available as per abstract)
- This study will provide novel insights into cardamom's therapeutic potential for T2DM.
- Findings may inform dietary recommendations for managing T2DM.
Introduction:
Cardamom possesses antioxidant, anti-inflammation, and blood pressure lowering properties, which might improve endothelial function in type 2 diabetic patients. However, no study has examined the effect of cardamom on diabetic patients. The present study aimed to examine the effects of 10-week green cardamom intake on blood pressure, concentrations of inflammatory and endothelial function biomarkers in type 2 diabetes mellitus patients, and its potential mechanisms.
Methods And Analysis Design:
Eighty overweight or obese patients with type 2 diabetes mellitus (aged 30-60 years) will be recruited into the trial and will assign to receive either cardamom (3 g/day, 6 capsules) or placebo (rusk powder, 6 capsules) for a period of 10 weeks. Systolic blood pressure and diastolic blood pressure, asymmetric dimethylarginine, and nitric oxide will be measured. Serum inflammatory markers namely interleukin 6, tumor necrosis factor-α, high-sensitivity C-reactive protein, and factors related to endothelial function including intercellular adhesion molecule-1, vascular cell adhesion molecule 1, CD62 antigen-like family member E, and cluster of differentiation 163 will be measured at baseline and at the end of the trial. Sociodemographic, International Physical Activity Questionnaire, and three 24-hour dietary recall questionnaires will be collected for each participant.
Ethics And Dissemination:
The study has been approved by The Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.REC.1395.2700). Each participant will sign a written informed consent at the beginning of the study. At the end of the study, results will be published timely manner.
Trial Registration Number:
(http://www.irct.ir, identifier: IRCT-2016042717254N5) Date of registration: 2016-11-23.
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