Effects of Xanthohumol on Metabolic Syndrome Progression

Last updated: June 6, 2018
Sponsor: Universidade do Porto
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Cholesterol (Hyperlipidemia)

Metabolic Syndrome

Metabolic Disorders

Treatment

N/A

Clinical Study ID

NCT03561116
XAN4Health
  • Ages 25-65
  • All Genders

Study 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.

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

Total Participants: 76
Study Start date:
May 19, 2018
Estimated Completion Date:
October 31, 2018

Connect with a study center

  • Medical Faculty of University of Porto

    Porto, 4200-319
    Portugal

    Active - Recruiting

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