CClinicalTrials.gg
Status unknownNCT03561116XAN4HealthUpdated Jun 19, 2018

Effects of Xanthohumol on Metabolic Syndrome Progression

An interventional study of XAN and Placebo in Metabolic Syndrome, sponsored by Universidade do Porto. Status unknown at 1 site in Portugal. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Metabolic Syndrome

Keywords

  • Metabolic Syndrome
  • Xanthohumol
  • Glucose metabolism
  • DNA damage
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 76 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    XAN

    XAN (1 sachet of 12 mg/day)

    Dietary Supplement: XAN

  • Placebo comparator
    Placebo

    Placebo (1 sachet with excipient)

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementXAN

    Daily intake of a sachet containing 12 mg of XAN

  • Dietary supplementPlacebo

    Daily intake of a sachet containing excipient

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Medical Faculty of University of Porto
    Porto, 4200-319, Portugal
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03561116
Lead sponsor
Universidade do Porto
Responsible party
Sponsor
First posted
Jun 19, 2018
Start date
May 19, 2018
Primary completion
Sep 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Jun 19, 2018

Study contacts

Raquel Soares, PhD
Contact
raqsoa@med.up.pt
(+351)225513624
Raquel Soares, PhD
principal investigator · Medical Faculty of University of Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion