Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

June 6, 2018 updated by: Universidade do Porto

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Raquel Soares, PhD
  • Phone Number: (+351)225513624
  • Email: raqsoa@med.up.pt

Study Locations

  • Portugal
      • Porto, Portugal, 4200-319
        • Recruiting
        • Medical Faculty of University of Porto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: Change from baseline of HbA1c at 3 months
Change from baseline of HbA1c at 3 months
Comet assay
Time Frame: Change from baseline of DNA damage at 3 months
Change from baseline of DNA damage at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
HDL-cholesterol
Time Frame: Change from baseline of HDL-cholesterol at 3 months
Change from baseline of HDL-cholesterol at 3 months
LDL-cholesterol
Time Frame: Change from baseline of LDL-cholesterol at 3 months
Change from baseline of LDL-cholesterol at 3 months
Triglycerides
Time Frame: Change from baseline of triglycerides at 3 months
Change from baseline of triglycerides at 3 months
Total-cholesterol
Time Frame: Change from baseline of total-cholesterol at 3 months
Change from baseline of total-cholesterol at 3 months
Waist circumference
Time Frame: Change from baseline of waist circumference at 3 months
Change from baseline of waist circumference at 3 months
Body weight
Time Frame: Change from baseline of body weight at 3 months
Change from baseline of body weight at 3 months
Body composition
Time Frame: Change from baseline of body composition at 3 months
Change from baseline of body composition at 3 months
Blood pressure
Time Frame: Change from baseline of blood pressure at 3 months
Change from baseline of blood pressure at 3 months
Heart rate
Time Frame: Change from baseline of heart rate at 3 months
Change from baseline of heart rate at 3 months
ApoB
Time Frame: Change from baseline of ApoB at 3 months
Change from baseline of ApoB at 3 months
ApoA1
Time Frame: Change from baseline of ApoA1 at 3 months
Change from baseline of ApoA1 at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raquel Soares, PhD, Medical Faculty of University of Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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