Phase
Condition
High Cholesterol (Hyperlipidemia)
Metabolic Syndrome
Metabolic Disorders
Treatment
N/AClinical Study ID
Ages 25-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women, 25-65 years of age;
Criteria for metabolic syndrome according to the 2005 revised NCEP ATP III guidelines:
HDL-C < 40 mg/dL ♂ and < 50 mg/dL ♀;
Triglycerides ≥ 150 mg/dL;
Blood pressure ≥ 130/85 mmHg;
Fasting plasma glucose ≥ 100 mg/dL;
Waist circumference ≥ 102 cm ♂ and ≥ 88 cm ♀;
HbA1c 5.8/6.0-6.4;
Nonsmokers or no other tobacco use in the last 3 months;
Willing to stop taking regular supplements including antioxidants for 2 weeks prior tostudy entry through conclusion of study;
Willing to stop consumption of beer for 2 weeks prior to study entry throughconclusion of study;
Must be able to provide informed consent;
Blood screen tests [comprehensive metabolic panel (CMP), and lipid profile] withinnormal limits or if outside normal limits, approved for participation at thediscretion of the study physician.
Exclusion
Exclusion Criteria:
Have a significant acute or chronic coexisting illness, such as cardiovasculardisease, chronic kidney or liver disease, gastrointestinal disorder, endocrinedisorder, immunological disorder, metabolic disease, cancer, chemotherapy history,gluten intolerance, eating disorders, depression or any psychiatric condition,diabetes, or any condition which contraindicates entry in the study, according to theinvestigators' judgment;
Currently taking prescription drugs other than oral contraceptives (over-the-countermedications are allowed upon review and discretion of the study physician);
Consumption of more than the recommended alcohol guidelines (> 1 drink/day ♀ and > 2drinks/day ♂);
Consumption of high levels of beer;
Pregnancy (as confirmed by urine pregnancy test) or planning to become pregnant beforecompleting the study;
Breastfeeding;
Under UV therapy (e.g. psoriasis treatment), using UV tanning beds and unprotected sunexposure greater than 1 hour/day;
Engaging in vigorous exercise more than 6 hours/week;
Participation in other dietary study in the past 3 months;
Had surgery in the last 3 months;
Post-menopausal status.
Study Design
Connect with a study center
Medical Faculty of University of Porto
Porto, 4200-319
PortugalActive - Recruiting

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