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临床试验/NCT05333315
NCT05333315已完成不适用

The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults

University of Primorska1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in body fat

研究概览

简要总结

In recent years, dietary supplement are of great interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical and anthropometric parameters.

详细描述

The incidence of obesity has been rapidly increasing, and this condition has become a major public health threat, since it is strongly linked with increased risk for several diseases including type 2 diabetes, cardiovascular disease, cancer and brain aging. Obesity and overweight are chronic disorders of multifactorial origin that are characterized by high oxidative status and by low chronic inflammation. Thus far, molecular mechanisms underlying obesity and obesity-related metabolic disorders have not been fully clarified, and effective therapeutic approaches to lower inflammation and oxidative stress are currently of general interest.

In recent years, dietary supplement and are of interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical (lipid profile, glucose, C-reactive protein, bilirubin, alanine aminotransferase, etc), and anthropometric parameters (body mass, the percentage of body fat, visceral fat index, etc,...). Food supplements are mainly composed of different fiber and other bioactive compounds.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •BMI > 25 kg/m2
  • •BMI > 25 kg/m2
  • •personally signed and dated informed consent form
  • •ability to understand and willingness to comply with all protocols required visits assessments and interventions

排除标准

  • •use of dietary supplements
  • •use of medication for any component of metabolic syndrome
  • •presence of inflammatory and/or autoimmune disorders
  • •pregnancy or lactating

研究组 & 干预措施

Investigation Product 1 (IP1) in softchews form

Experimental

0,5 g of glucomannan per softchew

干预措施: IP1 (Dietary Supplement)

Investigation Product 2 (IP2) in powder form

Experimental

Fiber of light Indian plantain, 7 g; glucomannan, 4,3 g; Inulin 2,5 g; Apple fiber, 1g; Choline, bitartrate 90 mg; Apple pectin,50 mg; Inositol, 40 mg

干预措施: IP2 (Dietary Supplement)

Investigation Product 4 (IP4) in liquid form

Experimental

LIQUID: Arabinogalactan, 700 mg; Inulin, 700 mg; Beta-glucans, 30 mg

干预措施: IP4 (Dietary Supplement)

Investigation Product 5 (IP5) in two capsules form

Experimental

CAPSULE 1:L-arginine, 100 mg; Choline bitartrate, 100 mg; L-carnosine, 100 mg; L-taurine, 100 mg; Soy lecithin, 50 mg; R-alfa lipoic acid,10 mg; Vitamin B6,2 mg; Folic acid, 200 µg; Vitamin D3, 5 µg; Vitamin B12, 2 µg CAPSULE 2: Schisandra fruit extract, 400 mg; Milk thistle fruit extract associated with phospholipids, 200 mg; Grape seed extract associated with phospholipids, 50 mg; Grape seed extract (Vitis vinifera),50 mg

干预措施: IP5 (Dietary Supplement)

Investigation Product 3 (IP3) in powder form and capsules form

Experimental

POWDER: Plantain fibre 10 g; Inulin, 2 g; Apple fibre, 1,5 g; Root of pellitory, 500 mg; Apple pectin, 450 mg CAPSULE: Pumpkin seed extract, 300 mg; Garlic extract odourless, 300 mg; Artichoke leaf extract, 150 mg; Cumin seed extract, 150 mg; Peppermint leaf extract, 150 mg; Anise seed extract, 150 mg; Curcuma rhizome extract, 150 mg; Vitamin C, 42 mg; Zinc (in gluconate),10 mg; Vitamin B6, 1,5 mg

干预措施: IP3 (Dietary Supplement)

结局指标

主要结局

Change in body fat

时间窗: eight weeks

Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

次要结局

  • Changes in waist circumference(eight weeks)
  • Blood pressure(eight weeks)
  • Inflammation(eight weeks)
  • Change in body weight(eight weeks)
  • Changes in visceral fat rating(eight weeks)
  • Lipid profile(eight weeks)
  • Changes in muscle mass(eight weeks)
  • Antioxidative potential(eight weeks)

研究者

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

Zala Jenko Praznikar

Associate professor

University of Primorska

研究点 (1)

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