Back to resultsEffects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
XAN
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage
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.
Sites / Locations
- Medical Faculty of University of PortoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XAN
Placebo
Arm Description
XAN (1 sachet of 12 mg/day)
Placebo (1 sachet with excipient)
Outcomes
Primary Outcome Measures
Glycated hemoglobin (HbA1c)
Comet assay
Secondary Outcome Measures
HDL-cholesterol
LDL-cholesterol
Triglycerides
Total-cholesterol
Waist circumference
Body weight
Body composition
Blood pressure
Heart rate
ApoB
ApoA1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03561116
Brief Title
Effects of Xanthohumol on Metabolic Syndrome Progression
Acronym
XAN4Health
Official Title
Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 19, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Xanthohumol, Glucose metabolism, DNA damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Triple blind
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XAN
Arm Type
Experimental
Arm Description
XAN (1 sachet of 12 mg/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (1 sachet with excipient)
Intervention Type
Dietary Supplement
Intervention Name(s)
XAN
Intervention Description
Daily intake of a sachet containing 12 mg of XAN
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily intake of a sachet containing excipient
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Time Frame
Change from baseline of HbA1c at 3 months
Title
Comet assay
Time Frame
Change from baseline of DNA damage at 3 months
Secondary Outcome Measure Information:
Title
HDL-cholesterol
Time Frame
Change from baseline of HDL-cholesterol at 3 months
Title
LDL-cholesterol
Time Frame
Change from baseline of LDL-cholesterol at 3 months
Title
Triglycerides
Time Frame
Change from baseline of triglycerides at 3 months
Title
Total-cholesterol
Time Frame
Change from baseline of total-cholesterol at 3 months
Title
Waist circumference
Time Frame
Change from baseline of waist circumference at 3 months
Title
Body weight
Time Frame
Change from baseline of body weight at 3 months
Title
Body composition
Time Frame
Change from baseline of body composition at 3 months
Title
Blood pressure
Time Frame
Change from baseline of blood pressure at 3 months
Title
Heart rate
Time Frame
Change from baseline of heart rate at 3 months
Title
ApoB
Time Frame
Change from baseline of ApoB at 3 months
Title
ApoA1
Time Frame
Change from baseline of ApoA1 at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Soares, PhD
Phone
(+351)225513624
Email
raqsoa@med.up.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Soares, PhD
Organizational Affiliation
Medical Faculty of University of Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Faculty of University of Porto
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Soares, PhD
Phone
(+351)225513624
Email
raqsoa@med.up.pt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Xanthohumol on Metabolic Syndrome Progression
We'll reach out to this number within 24 hrs