Effects of Dried Whole Fruits on Metabolism in Diabetes

Sponsor
University of Manitoba
Study ID
NCT07354386
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Freeze dried whole Saskatoon berry — DIETARY_SUPPLEMENT
    Freeze dried whole Saskatoon berry 40 g/day for 12 weeks
  • Freeze dried apple slice bulk — DIETARY_SUPPLEMENT
    Freeze dried apple slice bulk in same carbohydrate amount as 40 g Saskatoon berry per day for 12 weeks

Study Details

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.

Key Dates

First listed
Jan 21, 2026
Start date
Apr 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2032

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Freeze dried whole Saskatoon berry
    Freeze dried whole Saskatoon berry 40 g/day for 12 weeks
  • Placebo Comparator: 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

Primary Outcome Measure

Fasting plasma glucose (FPG) [ Time Frame: 12 weeks ]

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