Effects of Gum Arabic Supplementation on the Components of Metabolic Syndrome Among Post Menopausal Females in Khartoum State 2019
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nuclear Factor Kappa Beta concentration in nanogram/dl
研究概览
简要总结
Gum Arabic ingestion has been proved to decrease some of the inflammatory markers in some metabolic diseases that have an inflammatory background. Nevertheless, the mechanism/s by which it does so is uncertain. This study is targeting one of the postulated molecular mechanisms at genetic level that may help to understand how Gum Arabic exerts its effect .The effects of GA on Nuclear Factor Kappa Beta, P38 Mitogen Activated Protein (MAP) Kinase levels, and on the expression of inflammatory cytokines genes are going to be assessed in postmenopausal females with Metabolic Syndrome.
详细描述
The Metabolic syndrome (MetS) is a collection of several interconnected biochemical, clinical, and metabolic factors that directly increase the risk of atherosclerotic cardiovascular disease and Diabetes Mellitus.
Hypertension, Dyslipidemia, insulin resistance, obesity, glucose intolerance, proinflammatory and prothrombotic states are the cornerstone features defining the syndrome. Glycerol, free fatty acids (FFA), tumor necrosis factor alpha (TNFα), interleukin 6 (IL6), interleukin 1(IL-1) and Interferon Gamma (INFγ) are some of the inflammatory substances (cytokines) that are released from different cells (monocytes and adipocytes) in MetS.
Gum Arabic is found as a mixture of sodium, calcium and potassium salts of branched polysaccharides. In the colon, GA is fermented by colonic bacteria into short chain fatty acids such as butyrate, which are partially absorbed into blood.
Butyrate treatment was found to inhibit expression of cytokine mRNAs in peripheral blood monocytes (PBMC) that are stimulated by bacterial lipopolysaccharide (LPS).
In unstimulated (PBMC), a transcription factor (Nuclear Factor kappa β (NF-κB)) controls gene expression of some inflammatory cytokines; Tumor Necrosis Factor Alpha (TNF- α), IL-1 and IL-6. NF-κB was detected mainly in the cytoplasm tightly bound to an Inhibitory protein (IκB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Both the investigators and outcome assessors will be given codes of the participants for further analysis
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate
排除标准
- •Exclusion criteria
- •Patients with mental or physical disability
- •Use of corticosteroids or any other drug that affects body weight
- •History of Gum Arabic (GA) allergy
- •Chronicrenal or liver disease
- •Chronocinflammatory diseases
- •History of CVA or MI Participants will be asked to maintain their habitually daily diet and level of activity during the period of the study and to continue any previously prescribed medication.
研究组 & 干预措施
Single Arm
Hundred postmenopausal women were enrolled and received therapeutic dose of Gum Arabic (0.5 gm/kg/day) and followed for 12 weeks then the intended outcomes will be compared before and after completion of the study
干预措施: Gum Arabic (Drug)
结局指标
主要结局
Nuclear Factor Kappa Beta concentration in nanogram/dl
时间窗: 12 weeks
Nuclear regulatory protein
P38 Mitogen activated protein kinase in nanogram/dl
时间窗: 12 weeks
Transcription regulatory protein
Inhibitory Kappa Beta protein in nanogram/dl
时间窗: 12 weeks
inhibitory protein
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
时间窗: 12 weeks
Proinflammatory cytokines
Plasminogen activated protein inhibitor1 in picogram/dl
时间窗: 12 weeks
Protein Inhibitor
Fasting Insulin in nanogram/dl
时间窗: 12 weeks
Metabolic hormone
Insulin resistance by HOMA index
时间窗: 12 weeks
Measuring cells sensitivity to insulin
次要结局
- Fasting Blood Sugar in mg/dl(12 weeks)
- Lipid profile in mg/dl(12 weeks)
研究者
Fatima Elhaj
Principal Investigator
University of Khartoum