Researcher-blinded Randomized Controlled Trial of the Effects of Dried Whole Fruits on Glucose and Lipid Levels in Prediabetic and Type 2 Diabetic Individuals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose (FPG)
研究概览
简要总结
Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. 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 certain 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. Previous studies in the investigator's group 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 findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Preliminary studies by the investigators 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 SB 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 diabetic subjects. The investigators propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.
详细描述
Subject recruitment: Untreated prediabetes or new type 2 diabetic (T2D) patients (males and females, 18-74 years of age) and willing to sign an informed consent will be recruited from community clinics in Winnipeg, Endocrine or Hepatologic Clinics in University of Manitoba and Rossmere Medical Centre in Winnipeg by posters. Exclusion criteria include: 1) candidates have a history of myocardial infarction, stroke or chronic kidney disease; 2) participants treated with hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a month. Candidates will be invited to read and voluntarily sign an informed consent approved by Research Ethics Board in University of Manitoba. Recruitment goal: n = 92 (80 + 15% expected drop-off).
Randomization: Eligible participant will be enrolled and randomization into two groups through a web randomization tool. Randomized ID will be obtained for each participant used in files or labels on packages of dried fruits.
Dietary supplements: Freeze dried Saskatoon berry (SB) have been obtained from Prairie Berries Inc. The berries were freshly frozen and no 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. Control dietary supplement will be dried apple slice bulk without supplementation (Vancouver Freeze Dry, Langley, BC). Two types of dietary supplements will be weighed and packed: 1) 40 g of dried whole SB/bag; 2) dried apple slice bulk in a weight containing carbohydrate equivalent to 40 g of SB/bag). Non-transparent bags labeled only with randomization ID will be used for the package of the fruits.
Duration of the dietary regimen: 12 weeks.
Scheduled visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated pre-diabetes with or without fatty liver disease
- •Untreated type 2 diabetes with or without fatty liver disease
- •Males and females (18-74 years)
- •Signed informed consent
排除标准
- •Treated with hypoglycemic, hypolipidemic, anti-hypertensive or antibiotics within 1 month
- •Acute myocardial infarction, stroke, heart failure, chronic kidney disease, cirrhosis, metastatic cancers
- •Currently pregnancy or nursing
- •Allergy to fruits
研究组 & 干预措施
Freeze dried whole Saskatoon berry
Freeze dried whole Saskatoon berry 40 g/day for 12 weeks
干预措施: Freeze dried whole Saskatoon berry (Dietary Supplement)
Freeze dried apple slize bulk
Freeze dried apple slice bulk in the same carbohydrate amount as in 40 g of Saskatoon berry per day for 12 weeks
干预措施: Freeze dried apple slice bulk (Dietary Supplement)
结局指标
主要结局
Fasting plasma glucose (FPG)
时间窗: 12 weeks
FPG (mM/L, normal range 3.6-6.1 mM/L) will be measured chemically at baseline and end of the intervention
次要结局
- Hemaglobin A1C (HbA1c)(12 weeks)
- Total serum choleserol (TC)(12 weeks)
- Low density lipoprotein-cholesterol (LDL-c)(12 weeks)
- Triglycerides (TAG)(12 weeks)
- High density lipoprotein-cholesterol (HDL-c)(12 weeks)
- Apoprotein B (apoB)(12 weeks)
- Apoprotein A-I (apoA-I)(12 weeks)
- Insulin(12 weeks)
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(12 weeks)
- Glucagon-like peptide-1 (GLP-1)(12 weeks)
- High-sensitive C-reative protein (hs-CRP)(12 weeks)
- Aspartate transaminase (AST)(12 weeks)
- Alanine transaminase (ALT)(12 weeks)
- Conditioned Attenuation Paramer (CAP) from fibroscan(<12 months)
- Systolic blood pressure (SBP)(12 weeks)
- Diastolic blood pressure (DBP)(12 weeks)
- Body weights(12 weeks)
- Gut microbiome(12 weeks)
- Fecal short chain fatty acids (SCFA)(12 weeks)