Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)

Universidade do Porto

Status: Unknown

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: XAN; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03561116

XAN4Health

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

76 participants in 2 patient groups, including a placebo group

XAN

Experimental group

Description:

XAN (1 sachet of 12 mg/day)

Treatment:

Dietary Supplement: XAN

Placebo

Placebo Comparator group

Description:

Placebo (1 sachet with excipient)

Treatment:

Dietary Supplement: Placebo