Effects of Dried Whole Fruits on Metabolism in Diabetes

NCT07354386 | Enrolling By Invitation DMC

• 1 other identifier: HS26882 (B2025:027)
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes; Type 2 Diabetes

Keywords

Saskatoon berry; Dried apple; Fasting plasma glucose; Lipids; Insulin resistance; Inflammatory markers; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose (FPG)

  FPG (mM/L, normal range 3.6-6.1 mM/L) will be measured chemically at baseline and end of the intervention

  12 weeks

Secondary Outcomes (19)

• 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

Study Arms (2)

Freeze dried whole Saskatoon berry

EXPERIMENTAL

Freeze dried whole Saskatoon berry 40 g/day for 12 weeks

Dietary Supplement: Freeze dried whole Saskatoon berry

Freeze dried apple slize bulk

PLACEBO COMPARATOR

Freeze dried apple slice bulk in the same carbohydrate amount as in 40 g of Saskatoon berry per day for 12 weeks

Dietary Supplement: Freeze dried apple slice bulk

Interventions

Freeze dried whole Saskatoon berry DIETARY_SUPPLEMENT

Freeze dried whole Saskatoon berry 40 g/day for 12 weeks

Freeze dried whole Saskatoon berry

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

Freeze dried apple slize bulk

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Faculty of Health Sciences

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (8)

• du Preez R, Wanyonyi S, Mouatt P, Panchal SK, Brown L. Saskatoon Berry Amelanchier alnifolia Regulates Glucose Metabolism and Improves Cardiovascular and Liver Signs of Diet-Induced Metabolic Syndrome in Rats. Nutrients. 2020 Mar 27;12(4):931. doi: 10.3390/nu12040931.

  PMID: 32230955 BACKGROUND

• Zhao R, Shen GX. Impact of anthocyanin component and metabolite of Saskatoon berry on gut microbiome and relationship with fecal short chain fatty acids in diet-induced insulin resistant mice. J Nutr Biochem. 2023 Jan;111:109201. doi: 10.1016/j.jnutbio.2022.109201. Epub 2022 Nov 1.

  PMID: 36332818 BACKGROUND

• Zhao R, Xiang B, Dolinsky VW, Xia M, Shen GX. Saskatoon berry powder reduces hepatic steatosis and insulin resistance in high fat-high sucrose diet-induced obese mice. J Nutr Biochem. 2021 Sep;95:108778. doi: 10.1016/j.jnutbio.2021.108778. Epub 2021 May 15.

  PMID: 34004342 BACKGROUND

• Zhao R, Huang F, Shen GX. Dose-Responses Relationship in Glucose Lowering and Gut Dysbiosis to Saskatoon Berry Powder Supplementation in High Fat-High Sucrose Diet-Induced Insulin Resistant Mice. Microorganisms. 2021 Jul 21;9(8):1553. doi: 10.3390/microorganisms9081553.

  PMID: 34442633 BACKGROUND

• Huang F, Zhao R, Xia M, Shen GX. Impact of Cyanidin-3-Glucoside on Gut Microbiota and Relationship with Metabolism and Inflammation in High Fat-High Sucrose Diet-Induced Insulin Resistant Mice. Microorganisms. 2020 Aug 14;8(8):1238. doi: 10.3390/microorganisms8081238.

  PMID: 32824001 BACKGROUND

• Zhao R, Khafipour E, Sepehri S, Huang F, Beta T, Shen GX. Impact of Saskatoon berry powder on insulin resistance and relationship with intestinal microbiota in high fat-high sucrose diet-induced obese mice. J Nutr Biochem. 2019 Jul;69:130-138. doi: 10.1016/j.jnutbio.2019.03.023. Epub 2019 Apr 9.

  PMID: 31078906 BACKGROUND

• Zhao R, Xie X, Le K, Li W, Moghadasian MH, Beta T, Shen GX. Endoplasmic reticulum stress in diabetic mouse or glycated LDL-treated endothelial cells: protective effect of Saskatoon berry powder and cyanidin glycans. J Nutr Biochem. 2015 Nov;26(11):1248-53. doi: 10.1016/j.jnutbio.2015.05.015. Epub 2015 Jul 17.

  PMID: 26260864 BACKGROUND

• Zhao R, Le K, Li W, Ren S, Moghadasian MH, Beta T, Shen GX. Effects of Saskatoon berry powder on monocyte adhesion to vascular wall of leptin receptor-deficient diabetic mice. J Nutr Biochem. 2014 Aug;25(8):851-7. doi: 10.1016/j.jnutbio.2014.03.016. Epub 2014 Apr 13.

  PMID: 24925752 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 21, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)