Effects of Xanthohumol on Metabolic Syndrome Progression

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: XAN

• Registration Number: NCT03561116
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study Start: 2018-05-19
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-06
• Last Update Submitted: 2018-06-06
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19
• Primary Completion: 2018-09
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (1 sachet with excipient)
XAN	XAN	XAN (1 sachet of 12 mg/day)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
LDL-cholesterol	Change from baseline of LDL-cholesterol 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
HDL-cholesterol	Change from baseline of HDL-cholesterol 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
Triglycerides	Change from baseline of triglycerides 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
Total-cholesterol	Change from baseline of total-cholesterol at 3 months

Trial Locations

Locations (1)

Medical Faculty of University of Porto; 🇵🇹 Porto, Portugal