Effects of Xanthohumol on Metabolic Syndrome Progression

NCT ID: NCT03561116

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-19
• Study Completion Date: 2018-10-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XAN

XAN (1 sachet of 12 mg/day)

Group Type: EXPERIMENTAL

XAN

Intervention Type: DIETARY_SUPPLEMENT

Daily intake of a sachet containing 12 mg of XAN

Placebo

Placebo (1 sachet with excipient)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily intake of a sachet containing excipient

Interventions

XAN

Daily intake of a sachet containing 12 mg of XAN

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily intake of a sachet containing excipient

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raquel Soares, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty of University of Porto

Locations

Medical Faculty of University of Porto

Porto, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Raquel Soares, PhD

Role: CONTACT

raqsoa@med.up.pt

(+351)225513624

Facility Contacts

Raquel Soares, PhD

Role: primary

raqsoa@med.up.pt

(+351)225513624

Other Identifiers

XAN4Health

Identifier Type: -

Identifier Source: org_study_id