NCT07354386Enrolling by invitation
Effects of Dried Whole Fruits on Metabolism in Diabetes
Researcher-blinded Randomized Controlled Trial of the Effects of Dried Whole Fruits on Glucose and Lipid Levels in Prediabetic and Type 2 Diabetic Individuals
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 20 Apr 2026
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- University of Manitoba
- Diseases
- Type 2 diabetes
- NCT number
- NCT07354386
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 20 Apr 2026 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with hypoglycemic, hypolipidemic, anti-hypertensive or antibiotics within 1 month
Other illness
- Acute myocardial infarction, stroke, heart failure, chronic kidney disease, cirrhosis, metastatic cancers
- Allergy to fruits
Other
- Currently pregnancy or nursing
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Health Sciences Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.