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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03561116
Other study ID # XAN4Health
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2018
Est. completion date October 2018

Study information

Verified date May 2018
Source Universidade do Porto
Contact Raquel Soares, PhD
Phone (+351)225513624
Email raqsoa@med.up.pt
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date October 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
XAN
Daily intake of a sachet containing 12 mg of XAN
Placebo
Daily intake of a sachet containing excipient

Locations

Country Name City State
Portugal Medical Faculty of University of Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin (HbA1c) Change from baseline of HbA1c at 3 months
Primary Comet assay Change from baseline of DNA damage at 3 months
Secondary HDL-cholesterol Change from baseline of HDL-cholesterol at 3 months
Secondary LDL-cholesterol Change from baseline of LDL-cholesterol at 3 months
Secondary Triglycerides Change from baseline of triglycerides at 3 months
Secondary Total-cholesterol Change from baseline of total-cholesterol at 3 months
Secondary Waist circumference Change from baseline of waist circumference at 3 months
Secondary Body weight Change from baseline of body weight at 3 months
Secondary Body composition Change from baseline of body composition at 3 months
Secondary Blood pressure Change from baseline of blood pressure at 3 months
Secondary Heart rate Change from baseline of heart rate at 3 months
Secondary ApoB Change from baseline of ApoB at 3 months
Secondary ApoA1 Change from baseline of ApoA1 at 3 months
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