Metabolic SyndromeXAN4HealthNCT03561116
Effects of Xanthohumol on Metabolic Syndrome Progression
A study testing XAN in people with Metabolic Syndrome, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- XAN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 sitePortugal
- Study dates
- 19 May 2018to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Medical Faculty of University of Porto
Porto, 4200-319
Raquel Soares, PhD, (+351)225513624, raqsoa@med.up.pt
About this study
Official title: 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.
- Conditions
- Metabolic Syndrome
- Being tested
- XAN, Placebo
- Keywords
- Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XANDietary supplement
Daily intake of a sachet containing 12 mg of XAN
PlaceboDietary supplement
Daily intake of a sachet containing excipient
| Study group | Role | What they receive |
|---|---|---|
| XAN | Experimental | XAN (1 sachet of 12 mg/day) Receives: Dietary Supplement: XAN |
| Placebo | Placebo comparator | Placebo (1 sachet with excipient) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Measured: Change from baseline of HbA1c at 3 months
Comet assay
Measured: Change from baseline of DNA damage at 3 months
Secondary outcomes (11)
HDL-cholesterol
Measured: Change from baseline of HDL-cholesterol at 3 months
LDL-cholesterol
Measured: Change from baseline of LDL-cholesterol at 3 months
Triglycerides
Measured: Change from baseline of triglycerides at 3 months
Total-cholesterol
Measured: Change from baseline of total-cholesterol at 3 months
Waist circumference
Measured: Change from baseline of waist circumference at 3 months
Body weight
Measured: Change from baseline of body weight at 3 months
Body composition
Measured: Change from baseline of body composition at 3 months
Blood pressure
Measured: Change from baseline of blood pressure at 3 months
Heart rate
Measured: Change from baseline of heart rate at 3 months
ApoB
Measured: Change from baseline of ApoB at 3 months
ApoA1
Measured: Change from baseline of ApoA1 at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start19 May 2018
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raquel Soares, PhD, Principal investigator, Medical Faculty of University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561116
- Sponsor's protocol ID
- XAN4Health
- Acronym
- XAN4Health
- Status last verified
- May 2018
- First submitted
- 24 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
- ClinicalTrials.gov ID
- NCT03561116
- Acronym / sponsor ID
- XAN4Health / XAN4Health
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 19 May 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XAN | Experimental | Dietary Supplement: XANXAN (1 sachet of 12 mg/day) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (1 sachet with excipient) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men and women, 25-65 years of age;
- Criteria for metabolic syndrome according to the 2005 revised NCEP ATP III guidelines:
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XANDaily intake of a sachet containing 12 mg of XAN | Dietary supplement | XAN |
| PlaceboDaily intake of a sachet containing excipient | Dietary supplement | Placebo |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: Change from baseline of HbA1c at 3 months
Comet assay
Time frame: Change from baseline of DNA damage at 3 months
11 secondary outcomes
HDL-cholesterol
Time frame: Change from baseline of HDL-cholesterol at 3 months
LDL-cholesterol
Time frame: Change from baseline of LDL-cholesterol at 3 months
Triglycerides
Time frame: Change from baseline of triglycerides at 3 months
Total-cholesterol
Time frame: Change from baseline of total-cholesterol at 3 months
Waist circumference
Time frame: Change from baseline of waist circumference at 3 months
Body weight
Time frame: Change from baseline of body weight at 3 months
Body composition
Time frame: Change from baseline of body composition at 3 months
Blood pressure
Time frame: Change from baseline of blood pressure at 3 months
Heart rate
Time frame: Change from baseline of heart rate at 3 months
ApoB
Time frame: Change from baseline of ApoB at 3 months
ApoA1
Time frame: Change from baseline of ApoA1 at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Soares, PhD principal investigator
Medical Faculty of University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XAN in people with Metabolic Syndrome, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Soares, PhD ((+351)225513624, raqsoa@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: Change from baseline of HbA1c at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.