PACTR202305656080789尚未招募2 期
A Study of the Hypoglycemic Effect of African Traditional Fermented Foods amongst Pre-diabetic Adults.
Rosebella IsemeOndiek0 个研究点目标入组 252 人开始时间: 2023年4月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female individuals aged 18 – 65 years and above who are suffering from clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1c between 5.7% and 6.4%, who have sought clinic services at the selected AKU-outreach facility for at least 3 visits (including seeking services for separate reasons other than pre-diabetes for the purpose of ascertaining affiliation in an effort to minimize loss to follow).
排除标准
- •1. Currently on any of the following:
- •- glucose lowering medication (including insulin therapy)
- •- steroid therapy,
- •- immunosuppressive therapy,
- •- medication for gastric disease,
- •- warfarin or other coumarin derivates,
- •- Vitamin C or E, Iron or B12
- •- erythropoietin
- •- antiretrovirals
- •- ribavirin
- •2. Chronic use (defined as consumption of more than 3 months) of non-steroidal anti-inflammatory drugs or aspirin
- •3. Individuals that have consumed antibiotics in the last month.
- •4. Individuals that regularly consume fermented foods or took nutritional supplements including probiotics during the 3 months prior to screening. Regular consumption shall be defined as consuming at least 250ml of fermented foods on six days in a week.
- •5. Individuals who at the time of enrolment are smokers, regularly consume alcohol (defined as having had at least 12 drinks in the past year but 3 drinks or fewer per week, on average over the past year) or are suffering from drug addiction including chronic opiate use.
- •6. Individuals with a history of gastrointestinal surgery (gastrectomy, bariatric surgery, or colostomy), splenectomy or gastrointestinal malignancy.
- •7. Individuals known to be:
- •- HIV+ve,
- •- suffering from blood disorders such as Reticulocytosis or any form of Anaemia (including Iron deficiency, B12 Deficiency) or Haemoglobinopathies.
- •- Pregnant or lactating,
- •- with serious organic or metabolic conditions [such as malignant disease, pancreatitis, endocarditis, liver, or severe kidney disease (serum creatinine level above the normal range or macroalbuminuria including chronic renal failure), severe pulmonary or heart disease], splenomegaly, rheumatoid arthritis, hypertriglyceridemia, in a terminal stage of illness, or experiencing acute or severe episodes of mental illness at the time of enrolment.
- •8. Individuals with allergies to dairy or cereal products such as millet.
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