Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561116
Recruitment Status : Unknown
Verified May 2018 by Universidade do Porto.
Recruitment status was:  Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: XAN Dietary Supplement: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Triple blind
Primary Purpose: Treatment
Official Title: Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
Actual Study Start Date : May 19, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: Change from baseline of HbA1c at 3 months ]
  2. Comet assay [ Time Frame: Change from baseline of DNA damage at 3 months ]

Secondary Outcome Measures :
  1. HDL-cholesterol [ Time Frame: Change from baseline of HDL-cholesterol at 3 months ]
  2. LDL-cholesterol [ Time Frame: Change from baseline of LDL-cholesterol at 3 months ]
  3. Triglycerides [ Time Frame: Change from baseline of triglycerides at 3 months ]
  4. Total-cholesterol [ Time Frame: Change from baseline of total-cholesterol at 3 months ]
  5. Waist circumference [ Time Frame: Change from baseline of waist circumference at 3 months ]
  6. Body weight [ Time Frame: Change from baseline of body weight at 3 months ]
  7. Body composition [ Time Frame: Change from baseline of body composition at 3 months ]
  8. Blood pressure [ Time Frame: Change from baseline of blood pressure at 3 months ]
  9. Heart rate [ Time Frame: Change from baseline of heart rate at 3 months ]
  10. ApoB [ Time Frame: Change from baseline of ApoB at 3 months ]
  11. ApoA1 [ Time Frame: Change from baseline of ApoA1 at 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561116


Contacts
Layout table for location contacts
Contact: Raquel Soares, PhD (+351)225513624 raqsoa@med.up.pt

Locations
Layout table for location information
Portugal
Medical Faculty of University of Porto Recruiting
Porto, Portugal, 4200-319
Contact: Raquel Soares, PhD    (+351)225513624    raqsoa@med.up.pt   
Sponsors and Collaborators
Universidade do Porto
Investigators
Layout table for investigator information
Principal Investigator: Raquel Soares, PhD Medical Faculty of University of Porto
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03561116    
Other Study ID Numbers: XAN4Health
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
Metabolic Syndrome
Xanthohumol
Glucose metabolism
DNA damage
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases