Effects of Saskatoon Berry on Glucose Metabolism, Insulin Resistance and Gut Microbiota in Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose
研究概览
简要总结
Diabetes becomes epidemic in worldwide countries. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Our recent studies demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The results in anti-diabetic activities of SB powder have been supported by other groups in high fat fed rats. Our preliminary studies in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota. The combination of findings suggest that Saskatoon berry is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in healthy human subjects. We propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in healthy subjects in a single arm, open labeled phase I clinical trial.
详细描述
Subject recruitment: Healthy subjects and prediabetes (males and females, 18-75 years of age) in Winnipeg, who are voluntarily signing an informed consent approved by Research Ethics Board in University of Manitoba, will be eligible to the study. Exclusion criteria include: 1) candidates have a history of myocardial infarction, stroke, hypertension, diabetes, hyperlipidemia, chronic kidney disease; 2) participants are taking hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a month.
Dietary product: Freeze dried Saskatoon berry have been obtained from Prairie Berries Inc. The berries were freshly frozen and no any supplementation was added to the dried berry. The product has been processed by certified facilities and the batch of dried berry has passed pathogen analysis.
Regimen: Participants (n=20) will orally administrate 30 g/day of freeze dried Saskatoon berry during breakfast for 10 weeks.
Scheduled visits:
Visit 1: Consent and enrollment. A questionnaire for domestic questionnaire including dietary intake and physical activity will be filled. Measurements of body weight, height and blood pressure will be taken during the visit.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects living in Winnipeg.
- •Willingness to sign an informed consent.
排除标准
- •1. History of myocardial infarction, stroke, hypertension, diabetes, hyperlipidemia, chronic kidney disease.
- •2) Participants are taking hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a 1 month.
研究组 & 干预措施
Single arm
Single arm for healthy subjects using dried whole Saskatoon berry
干预措施: Saskatoon berry (Dietary Supplement)
Single arm
Single arm for healthy subjects using dried whole Saskatoon berry
干预措施: Dried Saskatoon berry (Dietary Supplement)
结局指标
主要结局
Fasting plasma glucose
时间窗: Changes from baseline to 10 weeks after the start of dietary intervention
Fasting plasma glucose in mM/L
Total serum cholesterol
时间窗: Changes from baseline to 10 weeks after the start of dietary intervention
Fasting total cholesterol in mM/L
次要结局
- Lipid profile beside total cholesterol(Onset and 10 weeks after the start of dietary intervention)
- C-reactive protein(Onset and 10 weeks after the start of dietary intervention)
- Liver enzymes(Onset and 10 weeks after the start of dietary intervention)
- Body mass index accord to body weight and height(Onset, 5 and 10 weeks after the start of dietary intervention)
- Blood pressure(Onset, 5 and 10 weeks after the start of dietary intervention)
- Gut micrbiota(Baseline and 10 weeks of SB intake)
- Glucagaon-like peptide(Between baseline and 10 weeks of SB intake)
- Insulin and homeostasis model assessment of insulin resistance (HOMA-IR)(Between baseline and 10 weeks of SB intake)
研究者
Garry Shen
Dr. Gary Shen
University of Manitoba