Effects of chia seeds on blood cholesterol and triglyceride levels

Completed

Conditions: Metabolic Syndrome (MeTS)
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN16949080

Lead Sponsor: Samnium Medical Cooperative

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Aged 18-83 years old
2. Caucasian
3. Have the following range values of serum cholesterol parameters at baseline:
3.1.TC, 200-260 mg/dL
3.2.HDL-C, 31-45 mg/dL
3.3.LDL-C, 190-205 mg/dL
3.4.TG, 170-280 mg/dL
4. Body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria

1. Smoking
2. Obesity (BMI >30 kg/m2)
3. Diabetes
4. Hepatic disease
5. Renal disease
6. Heart disease
7. Family history of chronic diseases
8. Drug therapy or supplement intake for hypercholesterolemia
9. Drug therapy or supplement intake containing apple polyphenols
10. Heavy physical exercise (more than10 hours per week)
11. Pregnant women, women suspected of being pregnant, women who hoped to become pregnant, breastfeeding
12. Birch pollen allergy
13. Use of vitamin/mineral supplements 2 weeks prior to entry into the study
14. Donation of blood less than 3 months before the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Plasma TC is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks<br>2. HDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks<br>3. LDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks<br>4. Triglyceride levels are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks

Secondary Outcome Measures

Name	Time	Method
1. Clinical history is measured by interviews and previous clinical data at baseline<br>2. Anthropometric measures are measured by taking height and weight at baseline, 4, 8, 12 and 16 weeks<br>3. Nutrient intake and dietary habits are measured using a seven day food record validated nutritional questionnaire at baseline, 4, 8, 12 and 16 weeks<br>4. Blood pressure is measured using a blood pressure cuff at baseline, 4, 8, 12 and 16 weeks<br>5. 24 hour ambulatory blood pressure is measured using blood pressure cuff at baseline, 4, 8, 12 and 16 weeks<br>6. Blood levels (AST, ALT, ?-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine) are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks