Effects of Xanthohumol on Metabolic Syndrome Progression
Mo kle
Abstrè
Dat
| Dènye verifye: | 04/30/2018 |
| Premye Soumèt: | 05/23/2018 |
| Enskripsyon Estimasyon Soumèt: | 06/05/2018 |
| Premye afiche: | 06/18/2018 |
| Dènye Mizajou Soumèt: | 06/05/2018 |
| Dènye Mizajou afiche: | 06/18/2018 |
| Dat aktyèl kòmanse etid la: | 05/18/2018 |
| Dat Estimasyon Prensipal Estimasyon an: | 08/31/2018 |
| Dat estime fini etid la: | 09/30/2018 |
Kondisyon oswa maladi
Entèvansyon / tretman
Dietary Supplement: XAN
Dietary Supplement: Placebo
Faz
Gwoup bra
| Bra | Entèvansyon / tretman |
|---|---|
| Experimental: XAN XAN (1 sachet of 12 mg/day) | Dietary Supplement: XAN Daily intake of a sachet containing 12 mg of XAN |
| Placebo Comparator: Placebo Placebo (1 sachet with excipient) | Dietary Supplement: Placebo Daily intake of a sachet containing excipient |
Kritè kalifikasyon yo
| Laj ki kalifye pou etid | 25 Years Pou 25 Years |
| Sèks ki kalifye pou etid | All |
| Aksepte Volontè Healthy | Wi |
| Kritè | 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. |
Rezilta
Mezi Rezilta Prensipal yo
1. Glycated hemoglobin (HbA1c) [Change from baseline of HbA1c at 3 months]
2. Comet assay [Change from baseline of DNA damage at 3 months]
Mezi Rezilta Segondè
1. HDL-cholesterol [Change from baseline of HDL-cholesterol at 3 months]
2. LDL-cholesterol [Change from baseline of LDL-cholesterol at 3 months]
3. Triglycerides [Change from baseline of triglycerides at 3 months]
4. Total-cholesterol [Change from baseline of total-cholesterol at 3 months]
5. Waist circumference [Change from baseline of waist circumference at 3 months]
6. Body weight [Change from baseline of body weight at 3 months]
7. Body composition [Change from baseline of body composition at 3 months]
8. Blood pressure [Change from baseline of blood pressure at 3 months]
9. Heart rate [Change from baseline of heart rate at 3 months]
10. ApoB [Change from baseline of ApoB at 3 months]
11. ApoA1 [Change from baseline of ApoA1 at 3 months]
