Effects of Xanthohumol on Metabolic Syndrome Progression

NCT03561116 | Unknown

• 1 other identifier: XAN4Health
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Xanthohumol; Glucose metabolism; DNA damage

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin (HbA1c)

  Change from baseline of HbA1c at 3 months

• Comet assay

  Change from baseline of DNA damage at 3 months

Secondary Outcomes (11)

• HDL-cholesterol

  Change from baseline of HDL-cholesterol at 3 months

• LDL-cholesterol

  Change from baseline of LDL-cholesterol at 3 months

• Triglycerides

  Change from baseline of triglycerides at 3 months

• Total-cholesterol

  Change from baseline of total-cholesterol at 3 months

• Waist circumference

  Change from baseline of waist circumference at 3 months

Study Arms (2)

XAN

EXPERIMENTAL

XAN (1 sachet of 12 mg/day)

Dietary Supplement: XAN

Placebo

PLACEBO COMPARATOR

Placebo (1 sachet with excipient)

Dietary Supplement: Placebo

Interventions

XAN DIETARY_SUPPLEMENT

Daily intake of a sachet containing 12 mg of XAN

XAN

Placebo DIETARY_SUPPLEMENT

Daily intake of a sachet containing excipient

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Medical Faculty of University of Porto

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raquel Soares, PhD

  Medical Faculty of University of Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Soares, PhD

CONTACT

(+351)225513624; raqsoa@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 19, 2018
• Study Start: May 19, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-05

Locations

PT (1)