Effects of Kale Consumption on Health and Nutritional Status among Adults with Metabolic Syndrome in Thailand

Phase 1

Completed

• Conditions: Adults aged between 25 to 59 years old with metabolic syndrome; Kale, Functional ingredient, Nutritional status, Metabolic syndrome

• Registration Number: TCTR20221129001
• Lead Sponsor: Program Management Unit for Competitiveness Enhancement (PMU-C)

Brief Summary

Consumption of fresh kale and kale-derived functional ingredient supplements significantly improved lipid profiles. Specifically, there was a notable reduction in total cholesterol and LDL-C levels, accompanied by a significant increase in HDL-C levels, particularly in the group receiving kale-derived supplements. Additionally, these interventions contributed to a reduced risk of cardiovascular events and showed a positive trend toward improvement in chronic low-grade inflammation and antioxidant status.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Study Completion: 2023-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1.) Male or female adults aged between 25-59 years old who lives in Bangkok and the vicinity area.
2.) There are at risk of metabolic syndrome as follows;
2.1 Waist circumference more than or equal to 90 cm for men, more than or equal to 80 cm for women, or Body Mass Index (BMI) more than or equal to 23 kg per m2, and or
2.2 Blood pressure more than 130/85 mm Hg, and or
2.3 Fasting blood results
- Fasting blood sugar above 100 mg / dL, and or
- Total cholesterol over 199 mg /dL, and or
- Triglyceride above 150 mg /dL, and or
- LDL-C over 130 mg/dl
3) Consent to participate in the study.

Exclusion Criteria

1. Diagnosed to be NCDs or taking medications such as hypertension, diabetes, liver disease, chronic kidney disease, cardiovascular disease (CVD), cancer, hyper/hypothyroidism, etc.
2. Diagnosed to be GI diseases or GI symptoms such as maldigestion and malabsorption
3. Unusual eating patterns such as weight reduction diet, vegetarian diet, vegan diet, etc.
4. Individuals who are using dietary supplements, herbal products, and hormones that effected to blood pressure and/or lipid profiles.
5. Presentation of any inflammation or infection
6. Currently smoking or alcohol drinking
7. Pregnant and lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight at 8 weeks after end of the intervention Weighing,Waist circumference at 8 weeks after end of the intervention Tape measure ,Blood pressure at 8 weeks after end of the intervention Non-invasive automated sphygmomanometer,Body compositions at 8 weeks after end of the intervention BIA Technology (Bioelectrical Impedance Analysis) ,Blood glucose at 8 weeks after end of the intervention Fasting blood glucose level analyzed by automatic biochemistry analyzer,Lipid profiles (Total Cholesterol, Triglyceride, HDL-C and LDL-C) at 8 weeks after end of the intervention Enzymatic colorimetric method,Inflammatory markers (IL-6 and TNF-alpha) at 8 weeks after end of the intervention ELISA (Enzyme-linked Immunosorbent Assay),Inflammatory markers (hs-CRP) at 8 weeks after end of the intervention Turbidimetric/Immunoturbidimetric,Antioxidant activity at 8 weeks after end of the intervention Oxygen Radical Absorbance Capacity (ORAC ) assay and Ferric Reducing Antioxidant Power (FRAP) assay

Secondary Outcome Measures

Name	Time	Method
Energy and nutrient intake at 4 weeks during the intervention and at 8 weeks after end of the intervention Three-day food record and INMUCAL-Nutrients program V. 4.0,Energy expenditure at 4 weeks during the intervention and at 8 weeks after end of the intervention Physical activity and exercise record (questionnaire) / Metabolic Equivalents Tasks (METs),Adverse effects at 4 weeks during the intervention and at 8 weeks after end of the intervention Adverse effects record (questionnaire)