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临床试验/NCT04904601
NCT04904601已完成不适用

Acute and Medium Effects of Freeze-dried Kale to Go, New Superfood Supplement to Reduce Metabolic Risk in Saudi Subjects

Chair for Biomarkers of Chronic Diseases2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

研究概览

简要总结

Whilst obesity represents a key risk factor for the development of metabolic disease and further premature mortality, the actual type of diet may provide the 'primary insults' for inflammation affecting systemic health in the pre-diabetic state such as obesity. Specifically, previous data indicate that a high-fat diet and/or unfavorable systemic lipid profiles can impair metabolic health which may occur via inflammatory mechanisms. The study aims to conduct a randomized interventional dietary trial with Freeze-dried Kale, as a superfood, to reduce inflammation and improve lipid profile in patients with obesity. These studies will analyze the effects of this superfood on metabolic changes among obese and non-obese Saudi women. Our hypothesis is the inclusion of Brassica into the daily diet will significantly improve metabolic health, microbiota composition, lower inflammatory insults (inflammasome), and lower microbial translocation, with resulting improvements in metabolic health. The team, therefore, proposes to examine the impact of the superfood kale on lipid function (acute and medium-term) over a 4 week dietary intervention period to assess the influence on metabolic change and biomarker changes. The team intends to utilize the expertise from a broad spectrum of specialists from plant biologists, clinical and allied health care professionals, and translational scientists, to provide a unique holistic insight into the role of nutrition for metabolic health benefits in human participants. These studies will provide us with the capacity to use a directly applicable dietary supplement, freeze-dried Kale, to improve the health of people metabolically. As this is a natural product, this will have the capability to reach the market much quicker and advance research at a much faster pace. This dietary supplement will also provide an additional measure to improve the health across the general public not just those at increased risk of disease to help provide another way to improve health among Saudis.

详细描述

Subjects Selection:

For this study we will recruit a total of 100 obese age matched non-diabetic Saudi women, (age 18-40 years; BMI 30-40Kg/m2) through college clinics in applied medical sciences college, KSU. The study participants exclusion criteria in brief: age under 18 or above 40 years, any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome); chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.

Sample and Data Collections:

Anthropometry and body composition as well as biochemical data will be undertaken for all visits, including blood, urine and stool collection. Serum will be collected all patients for later analysis. All samples collected will be stored appropriately for biochemical analysis within the Bio-Bank facilities, in the Chair for Biomarkers of Chronic Diseases in King Saud University. All samples will be stored at -80oC following the appropriate protocol extraction methods.

Intervention:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Both the participant and investigator are blinded. Randomization and blinding will be done by a third party.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese (BMI 30-40Kg/m2 and above)
  • Aged 18-40 years
  • Saudi nationality

排除标准

  • Age under 18 or above 40 years
  • Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome)
  • Those with chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.
  • Expatriates

结局指标

主要结局

Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

时间窗: 2 weeks

Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.

Study the medium-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

时间窗: 4 weeks

Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.

次要结局

  • Study the acute and medium term effects of Kale Superfood on insulin levels(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on alanine aminotransferase levels(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on BMI(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on glucose levels(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on aspartate aminotransferase levels(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on HbA1c levels(6 weeks)
  • Study the acute and medium term effects of Kale Superfood on C-peptide levels(6 weeks)

研究者

发起方
Chair for Biomarkers of Chronic Diseases
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Dara Aldisi

Assistant Professor

Chair for Biomarkers of Chronic Diseases

研究点 (2)

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