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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XAN | Experimental | XAN (1 sachet of 12 mg/day) |
|
| Placebo | Placebo Comparator | Placebo (1 sachet with excipient) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XAN | Dietary Supplement | Daily intake of a sachet containing 12 mg of XAN |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Change from baseline of HbA1c at 3 months | |
| Comet assay | Change from baseline of DNA damage at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HDL-cholesterol | Change from baseline of HDL-cholesterol at 3 months | |
| LDL-cholesterol | Change from baseline of LDL-cholesterol at 3 months | |
| Triglycerides |
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Inclusion Criteria:
Men and women, 25-65 years of age;
Criteria for metabolic syndrome according to the 2005 revised NCEP ATP III guidelines:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raquel Soares, PhD | Contact | (+351)225513624 | raqsoa@med.up.pt |
| Name | Affiliation | Role |
|---|---|---|
| Raquel Soares, PhD | Medical Faculty of University of Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Faculty of University of Porto | Recruiting | Porto | 4200-319 | Portugal |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Triple blind
| Placebo |
| Dietary Supplement |
Daily intake of a sachet containing excipient |
|
| 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 |
| Body composition | Change from baseline of body composition 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 |
| D009750 |
| Nutritional and Metabolic Diseases |