Effects of Xanthohumol on Metabolic Syndrome Progression

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: XAN
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XAN<br>XAN (1 sachet of 12 mg/day) | Dietary Supplement: XAN<br>* Daily intake of a sachet containing 12 mg of XAN<br>|
| Placebo Comparator: Placebo<br>Placebo (1 sachet with excipient) | Dietary Supplement: Placebo<br>* Daily intake of a sachet containing excipient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage