Saskatoon Berries for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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. Our previous 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 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. 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 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. We 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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-74 with untreated pre-diabetes or type 2 diabetes, which may include those with fatty liver disease. Participants must not have started any treatment and should be willing to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Consent and enrollment, dietary intake and physical activity questionnaire, body weight, height, and blood pressure measurements
Treatment
Participants receive 40 g/day of freeze-dried Saskatoon berry or control dried apple slice for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including biochemical analyses and gut microbiome assessment
What Are the Treatments Tested in This Trial?
Interventions
- Freeze dried whole Saskatoon berry
Trial Overview
The study tests the effects of consuming freeze-dried whole Saskatoon berries versus apples on blood sugar control, insulin resistance, and gut bacteria in people with pre-diabetes or newly diagnosed type 2 diabetes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Freeze dried whole Saskatoon berry 40 g/day for 12 weeks
Freeze dried apple slice bulk in the same carbohydrate amount as in 40 g of Saskatoon berry per day for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.