An interventional study of Saskatoon berry and Dried Saskatoon berry in Nutritional and Metabolic Diseases, sponsored by University of Manitoba. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
Diabetes becomes epidemic in worldwide countries. 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 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 recent 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 results in anti-diabetic activities of SB powder have been supported by other groups 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 Saskatoon berry 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 healthy human subjects. We propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in healthy subjects in a single arm, open labeled phase I clinical trial.
Subject recruitment: Healthy subjects and prediabetes (males and females, 18-75 years of age) in Winnipeg, who are voluntarily signing an informed consent approved by Research Ethics Board in University of Manitoba, will be eligible to the study. Exclusion criteria include: 1) candidates have a history of myocardial infarction, stroke, hypertension, diabetes, hyperlipidemia, chronic kidney disease; 2) participants are taking hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a month.
Dietary product: Freeze dried Saskatoon berry have been obtained from Prairie Berries Inc. The berries were freshly frozen and no any 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.
Regimen: Participants (n=20) will orally administrate 30 g/day of freeze dried Saskatoon berry during breakfast for 10 weeks.
Scheduled visits:
Visit 1: Consent and enrollment. A questionnaire for domestic questionnaire including dietary intake and physical activity will be filled. Measurements of body weight, height and blood pressure will be taken during the visit.
Visit 2 (\<1 week from the visit 1 and before the start of berry administration): 75 g oral glucose tolerance test (OGTT) after an overnight fasting. Insulin, glucagon-like peptide-1 (GLP-1), liver enzymes (alanine transaminase or ALT, aspartate transaminase or AST), creatinine, lipid profile and inflammation markers (high-sensitive C-reactive protein or hs-CRP) will be measured as baseline. Stool samples will be collected in stool DNA preservation and collection kit.
Participants will be provided with sealed packages of dried Saskatoon berry and instruction of the administration. Insulin and lipid profile will be tested in blood samples withdrawn at fast glucose for OGTT.
Visit 3 (at 5 weeks after the start of administration of Saskatoon berry): Participants will be asked to provide feedback on general well-being and the intake of Saskatoon berry. Body weight, blood pressure and heart rate will be measured and recorded.
Visit 4 (at 10 weeks after the start of the dietary regimen): Participants will be asked to collect stool sample with the collection kit within 1 week before the visit and bring it to the visit. They will also be asked to have an overnight fasting the night before visit. They will receive blood withdrawal for biochemical tests and OGTT as the same as visit 2. During the visit, body weight, blood pressure and heart rate of participants will be taken. Questionnaires on participants' dietary intake, physical activity and feedback to the study will be completed.
Participants will receive a $50 honorarium gift card for their participation. Sample collection and analyses: OGTT, ALT, AST, creatinine and lipid profile will be analyzed in Clinical Chemistry in Health Science Centre, Winnipeg. Insulin, hs-CRP and GLP-1 will be analyzed in the Dr. G. Shen's laboratory. Homeostatic model assessment-insulin resistance or homeostatic model assessment for insulin resistance (HOMA-IR) will be calculated based on fasting plasma glucose and insulin. Stool samples will be aliquoted and stored under -80°C before submission. Microbiome analysis will be conducted in Integrate Microbiome Resource at Dalhousie University. Fecal short chain fatty acids (SCFA) will be measured in Microbiome Insight in University of British Columbia.
21 studies on the registry are indexed under Nutritional and Metabolic Diseases; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 93 across 17 interventional studies indexed under Nutritional and Metabolic Diseases.
Browse Nutritional and Metabolic Diseases studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. History of myocardial infarction, stroke, hypertension, diabetes, hyperlipidemia, chronic kidney disease.
2) Participants are taking hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a 1 month.
Single arm for healthy subjects using dried whole Saskatoon berry
Dietary Supplement: Saskatoon berry · Dietary Supplement: Dried Saskatoon berry
Freeze dried Saskatoon berry (30 g) will be orally administrated daily for 10 weeks.
Prediabetic patients (fasting glucose 5.6-6.9 mM/L, HbA1c 5.7-6.9%, or OGTT 2 h glucose 7.8-11 mM/L) will be randomized in two groups. One group participants will take 40g of dried Saskatoon berry/day for 12 weeks. Another group will take 40g of dried Saskatoon berry/day for 12 weeks,
Fasting plasma glucose
Fasting plasma glucose in mM/L
Time frame: Changes from baseline to 10 weeks after the start of dietary intervention
Total serum cholesterol
Fasting total cholesterol in mM/L
Time frame: Changes from baseline to 10 weeks after the start of dietary intervention
Lipid profile beside total cholesterol
Triglycerides, LDL-cholesterol, HDL-cholesterol and non-HDL-cholesterol in mM/L
Time frame: Onset and 10 weeks after the start of dietary intervention
C-reactive protein
C-reactive protein in mg/L
Time frame: Onset and 10 weeks after the start of dietary intervention
Liver enzymes
ALT, AST in units/L
Time frame: Onset and 10 weeks after the start of dietary intervention
Body mass index accord to body weight and height
Body weight in kg, heights in cm, and body mass index in kg/M\^2
Time frame: Onset, 5 and 10 weeks after the start of dietary intervention
Blood pressure
Systolic and diastolic blood pressure in mmHg
Time frame: Onset, 5 and 10 weeks after the start of dietary intervention
Gut micrbiota
16S-rRNA sequencing of stool samples
Time frame: Baseline and 10 weeks of SB intake
Glucagaon-like peptide
Plasma levels analyzed using ELISA
Time frame: Between baseline and 10 weeks of SB intake
Insulin and homeostasis model assessment of insulin resistance (HOMA-IR)
Fasting plasma insulin analyzed using ELISA and HOMA-IR estimated via simultaneous plasma glucose and insulin
Time frame: Between baseline and 10 weeks of SB intake
Dietary intake, physical activities
3 day food intake and the type in gram, frequency in time/day and length of physical activities index in artificial score (score scale 0-3, high means more activity)
Time frame: Onset and 10 weeks after the start of dietary intervention
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nutritional and Metabolic Diseases→
University of Manitoba