Metabolic Syndrome
Conditions
Keywords
Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage
Brief summary
A huge body of scientific evidence has suggested that xanthohumol (XAN) consumption, a polyphenol present in beer, has a positive effect on energy metabolism. This compound is known for its antioxidant, anti-inflammatory and anti-cancer properties which confer potential to be used as a food supplement. Nevertheless, XAN lipophilic properties prevent the extensive use of this molecule as a functional food compound. The company TA-XAN S.A.M. (Wiesbaden, Germany) has patented a method to overcome this solubility problem. So, the main aim of this study is to evaluate the effects of XAN consumption on metabolic syndrome progression in individuals recently diagnosed.
Interventions
DIETARY_SUPPLEMENTXAN
Daily intake of a sachet containing 12 mg of XAN
DIETARY_SUPPLEMENTPlacebo
Daily intake of a sachet containing excipient
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple blind
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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 to study entry through conclusion of study; * Willing to stop consumption of beer for 2 weeks prior to study entry through conclusion of study; * Must be able to provide informed consent; * Blood screen tests \[comprehensive metabolic panel (CMP), and lipid profile\] within normal limits or if outside normal limits, approved for participation at the discretion of the study physician.
Exclusion criteria
* Have a significant acute or chronic coexisting illness, such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, 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 the investigators' judgment; * Currently taking prescription drugs other than oral contraceptives (over-the-counter medications are allowed upon review and discretion of the study physician); * Consumption of more than the recommended alcohol guidelines (\> 1 drink/day ♀ and \> 2 drinks/day ♂); * Consumption of high levels of beer; * Pregnancy (as confirmed by urine pregnancy test) or planning to become pregnant before completing the study; * Breastfeeding; * Under UV therapy (e.g. psoriasis treatment), using UV tanning beds and unprotected sun exposure 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c) | Change from baseline of HbA1c at 3 months |
| Comet assay | Change from baseline of DNA damage at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides | Change from baseline of triglycerides at 3 months |
| Total-cholesterol | Change from baseline of total-cholesterol at 3 months |
| Waist circumference | Change from baseline of waist circumference at 3 months |
| Body weight | Change from baseline of body weight at 3 months |
| HDL-cholesterol | Change from baseline of HDL-cholesterol at 3 months |
| Blood pressure | Change from baseline of blood pressure at 3 months |
| Heart rate | Change from baseline of heart rate at 3 months |
| ApoB | Change from baseline of ApoB at 3 months |
| ApoA1 | Change from baseline of ApoA1 at 3 months |
| Body composition | Change from baseline of body composition at 3 months |
| LDL-cholesterol | Change from baseline of LDL-cholesterol at 3 months |
Countries
Portugal
Contacts
Primary ContactRaquel Soares, PhD
Outcome results
None listed