Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: XAN; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Medical Faculty of University of Porto
    • Contact: Raquel Soares, PhD; Phone Number: (+351)225513624; Email: raqsoa@med.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XAN; XAN (1 sachet of 12 mg/day)	Dietary supplement: XAN; Daily intake of a sachet containing 12 mg of XAN
Placebo Comparator: Placebo; Placebo (1 sachet with excipient)	Dietary supplement: Placebo; Daily intake of a sachet containing excipient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Principal Investigator: Raquel Soares, PhD, Medical Faculty of University of Porto

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; DNA damage; Glucose metabolism; Xanthohumol
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: XAN4Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No