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临床试验/NCT05371340
NCT05371340已完成不适用

The Efficacy of Quercetin Supplementation on Bone Turnover Markers, Inflammatory Markers, Body Composition, and Physical Function in Post-Menopausal Women

Kennesaw State University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
CRP mg/L

研究概览

简要总结

Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables, and is considered to be a potent antioxidant with several expected health benefits such as anti-inflammatory effects and bone-conserving properties. Participants will supplement with either Quercetin, or placebo, for 90-days with pre- and post-testing visits.

详细描述

Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables such as onions, apples, berries, green tea, and red wine and is currently an FDA approved supplement. Quercetin is considered to be a potent antioxidant with several expected health benefits. Both in vivo and in vitro studies have demonstrated that quercetin acts as a potent natural osteogenic agent with benefits that include anti-inflammatory effects and bone-conserving properties. Quercetin is suggested to protect against bone loss by inhibiting bone resorption and stimulating bone formation which is indicated by an increase in bone mineral density and bone formation markers such as osteocalcin.

The purpose of this study is to investigate the effects of quercetin supplementation on bone, specifically on bone turnover markers, in postmenopausal women. The interplay between cytokines (i.e., IL-6, CRP, and TNF-alpha) and bone turnover markers was also considered.

In a double-blind, placebo-controlled fashion, we aimed to recruit 50, healthy, postmenopausal women between the ages of 45-75 years to participate in a 90-day supplement trial. Participants will be randomly assigned to one of two supplement groups: 1) quercetin 500 mg, once per day, or 2) placebo (methyl cellulose E4M) 500 mg, once per day for 90-days.

Participants will be asked to visit the laboratory (KSU Human Performance Laboratory) on 2 separate occasions for pre- and post-testing visits consisting of body composition measurements and blood draws by a CITI approved/IRB approved research team member trained in phlebotomy under the supervision of Dr. VanDusseldorp.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinically defined as postmenopausal (absence of menstrual cycle for 12 months without contraceptives or the surgical removal of the reproductive organs)
  • Activity levels ranging from sedentary to recreationally active were included in the study.

排除标准

  • Hyper- or hypothyroidism (uncontrolled)
  • Hyper- or hypoparathyroidism
  • Gastrointestinal disorders
  • Renal disorders
  • Orthopedic disorders
  • Rheumatological disorders
  • Immunological disorders
  • Type I diabetic
  • Being treated with any diabetic injectable medication(s).
  • Taking any non-steroidal, steroidal, or anti-inflammatory drugs
  • Currently, or in the past 1 month, were consuming daily calcium
  • Currently, or in the past 1 month, were consuming more than 5,000 IU's of vitamin D supplements
  • Taking any anti-obesity medications
  • Taking any osteoporotic medication(s)
  • Taking any long-term antibiotics.
  • Current smoker
  • Diagnosed with osteoporosis, or if their BMD was equal to, or fell below -2.50 via dual x-ray absorptiometry (DXA) during visit 1
  • Involved in heavy resistance training
  • Began a new unaccustomed exercise routine during the 90-days
  • Allergies to food(s) rich in QUE such as onions, apples, or berries; or if they were unwilling to avoid quercetin-containing foods.

结局指标

主要结局

CRP mg/L

时间窗: 90-days

C-reactive protein inflammatory marker.

BMD g/cm^2

时间窗: 90-days

Total, lumbar, right and left femur, and left forearm bone mineral density

Osteocalcin ng/mL

时间窗: 90-days

Bone formation marker

TNF-alpha pg/mL

时间窗: 90-days

Tumor necrosis factor-alpha inflammatory marker

FBG mg/dl

时间窗: 90-days

Fasting blood glucose

CTX ng/L

时间窗: 90-days

Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.

PINP ug/L

时间窗: 90-days

Procollagen type-I N-terminal propeptide. Bone formation marker.

IL-6 pg/mL

时间窗: 90-days

Interleukin-6 inflammatory marker.

次要结局

  • Timed up and go (seconds)(90-days)
  • Dominant handgrip strength (kg)(90-days)
  • Body composition(90-days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trisha VanDusseldorp

Director

Kennesaw State University

研究点 (2)

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