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临床试验/NCT03705845
NCT03705845进行中(未招募)1 期

Actions of Dietary Tocotrienols on Obesity

Texas Tech University Health Sciences Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月15日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
visceral adipose tissue

研究概览

简要总结

Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators will enroll 60 qualified women at the start of the study and randomly assigned to no tocotrienols (placebo) or tocotrienols group for 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. All data will be analyzed statistically.

详细描述

Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Among these risk factors, obesity is now recognized as a worldwide epidemic disease. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Aging and decline of estrogen are factors that contribute to weight gain in postmenopausal women, and approaches, such as anti-inflammatory potential in dietary antioxidants to reduce inflammation may likely combat obesity. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. However, no study has ever been done the role of tocotrienols in obesity-associated outcome measures in postmenopausal women. The long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for mitigating obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. The investigators plan to enroll approximately 150-200 women to obtain 60 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols or tocotrienols group. The outcome measures will be assessed at baseline, after 12, and after 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. The investigators will monitor safety of subjects after 12 and after 24 weeks. Food intake and physical activity will be assessed at baseline, after 12, and after 24 weeks. All data will be analyzed statistically.

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

性别
Female
接受健康志愿者

入选标准

  • PMW with BMI ≥30 kg/m
  • Normal liver, kidney, and thyroid function (TSH)-sent to Quest Diagnostic Laboratory.
  • Sedentary using International Physical Activity Questionnaire (IPAQ-short form).
  • Exclusion criteria
  • Unstable body weight (more than 5% change in body weight) within 3 months before intervention begins.
  • Changes to medications or supplements (i.e., steroids, statins) within 3 months of the baseline study visit that could affect lipid metabolism. • If they change any medications/supplements after the baseline visit that will affect lipid metabolism, their study participation will end.
  • Taking anticoagulants that may interact with TT.
  • Serious chronic disease (e.g., unstable cardiovascular disease, uncontrolled diabetes and hypertension, and active cancer).

排除标准

  • 未提供

研究组 & 干预措施

Control

Placebo Comparator

One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.

干预措施: placebo softgel (Drug)

Intervention

Active Comparator

One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold® Tocotrienol 70%) contains 430 mg tocotrienol (90% δ-tocotrienol+10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.

干预措施: DeltaGold® Tocotrienol 70% (Drug)

结局指标

主要结局

visceral adipose tissue

时间窗: 24 weeks

VAT by BIA

Fat mass

时间窗: 24 weeks

total and regional fat mass by DXA

次要结局

  • Gut microbiota(24 weeks)
  • hs-CRP(24 weeks)
  • leptin(24 weeks)
  • HDL(24 weeks)
  • Oxylipins inflammation marker(24 weeks)
  • total cholesterol(24 weeks)
  • FASN(24 weeks)
  • beta-oxidation(24 weeks)
  • endocannabinoids inflammatory markers(24 weeks)
  • TG(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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