Clinical trial NCT03561116: Effects of Xanthohumol on Metabolic Syndrome Progression
Official title: Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Xanthohumol
Glucose metabolism
DNA damage
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: Change from baseline of HbA1c at 3 months
measure: Comet assay
timeFrame: Change from baseline of DNA damage at 3 months
Secondary outcomes:
measure: HDL-cholesterol
timeFrame: Change from baseline of HDL-cholesterol at 3 months
measure: LDL-cholesterol
timeFrame: Change from baseline of LDL-cholesterol at 3 months
measure: Triglycerides
timeFrame: Change from baseline of triglycerides at 3 months
measure: Total-cholesterol
timeFrame: Change from baseline of total-cholesterol at 3 months
measure: Waist circumference
timeFrame: Change from baseline of waist circumference at 3 months
measure: Body weight
timeFrame: Change from baseline of body weight at 3 months
measure: Body composition
timeFrame: Change from baseline of body composition at 3 months
measure: Blood pressure
timeFrame: Change from baseline of blood pressure at 3 months
measure: Heart rate
timeFrame: Change from baseline of heart rate at 3 months
measure: ApoB
timeFrame: Change from baseline of ApoB at 3 months
measure: ApoA1
timeFrame: Change from baseline of ApoA1 at 3 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Medical Faculty of University of Porto
Study officials:
affiliation: Medical Faculty of University of Porto
name: Raquel Soares, PhD
role: PRINCIPAL_INVESTIGATOR
References: