Effects of Xanthohumol on Metabolic Syndrome Progression

Metabolic Syndrome Clinical Trial

— XAN4Health  

Official title:

Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561116
• Other study ID #: XAN4Health
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2018
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: Universidade do Porto
• Contact: Raquel Soares, PhD
• Phone: (+351)225513624
• Email: raqsoa[@]med.up.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• XAN
Daily intake of a sachet containing 12 mg of XAN
• Placebo
Daily intake of a sachet containing excipient

Locations

Country	Name	City	State
Portugal	Medical Faculty of University of Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)		Change from baseline of HbA1c at 3 months
Primary	Comet assay		Change from baseline of DNA damage at 3 months
Secondary	HDL-cholesterol		Change from baseline of HDL-cholesterol at 3 months
Secondary	LDL-cholesterol		Change from baseline of LDL-cholesterol at 3 months
Secondary	Triglycerides		Change from baseline of triglycerides at 3 months
Secondary	Total-cholesterol		Change from baseline of total-cholesterol at 3 months
Secondary	Waist circumference		Change from baseline of waist circumference at 3 months
Secondary	Body weight		Change from baseline of body weight at 3 months
Secondary	Body composition		Change from baseline of body composition at 3 months
Secondary	Blood pressure		Change from baseline of blood pressure at 3 months
Secondary	Heart rate		Change from baseline of heart rate at 3 months
Secondary	ApoB		Change from baseline of ApoB at 3 months
Secondary	ApoA1		Change from baseline of ApoA1 at 3 months