PrediabetesNCT07354386
Effects of Dried Whole Fruits on Metabolism in Diabetes
A study testing Freeze dried whole Saskatoon berry and Freeze dried apple slice bulk in people with Prediabetes and Type 2 Diabetes, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Prediabetes, Type 2 Diabetes
- What is being tested?
- Freeze dried whole Saskatoon berry and Freeze dried apple slice bulk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Researcher-blinded Randomized Controlled Trial of the Effects of Dried Whole Fruits on Glucose and Lipid Levels in Prediabetic and Type 2 Diabetic Individuals
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.
Read the detailed description
Subject recruitment: Untreated prediabetes or new type 2 diabetic (T2D) patients (males and females, 18-74 years of age) and willing to sign an informed consent will be recruited from community clinics in Winnipeg, Endocrine or Hepatologic Clinics in University of Manitoba and Rossmere Medical Centre in Winnipeg by posters. Exclusion criteria include: 1) candidates have a history of myocardial infarction, stroke or chronic kidney disease; 2) participants treated with hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a month. Candidates will be invited to read and voluntarily sign an informed consent approved by Research Ethics Board in University of Manitoba. Recruitment goal: n = 92 (80 + 15% expected drop-off).
Randomization: Eligible participant will be enrolled and randomization into two groups through a web randomization tool. Randomized ID will be obtained for each participant used in files or labels on packages of dried fruits.
Dietary supplements: Freeze dried Saskatoon berry (SB) have been obtained from Prairie Berries Inc. The berries were freshly frozen and no 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. Control dietary supplement will be dried apple slice bulk without supplementation (Vancouver Freeze Dry, Langley, BC). Two types of dietary supplements will be weighed and packed: 1) 40 g of dried whole SB/bag; 2) dried apple slice bulk in a weight containing carbohydrate equivalent to 40 g of SB/bag). Non-transparent bags labeled only with randomization ID will be used for the package of the fruits.
Duration of the dietary regimen: 12 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): Blood withdrawal at Health Sciences Center (HSC) in Winnipeg after an overnight fasting. Fasting plasma glucose, insulin, HbA1C, lipid profile, liver enzymes (alanine transaminase or ALT, aspartate transaminase or AST), apoB, apoA-I, and creatinine will be analyzed in Clinical Chemistry in HSC. An extra 3 ml of blood withdraw in serum tube. The serum will be temporarily stored in Clinical Chemistry for measuring insulin, GLP-1 and high-sensitive C-reactive protein (hs-CRP) by Investigator's group.
Visit 3 (at 6 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 12 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. Blood samples will be collected for biochemical analyses as descried in Visit 2. Same amount blood will be collected for serum temporarily stored for the analysis of GLP-1 and hs-CRP. 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. 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 shipment to analysis in Integrate Microbiome Resource at Dalhousie University.
Data collection and analysis: Biochemical, physical exam, questionnaires, surveys, results from gut microbiota and SCFAs will be collected and inputted to password protected computers of PI and Project Coordinator with only ID but not names or other identifiable information. Data will be analyzed using standards statistical software and tools.
Expected outcomes Primary outcome: Fasting plasma glucose at the end of 12 weeks of SB intake compared to baseline.
Secondary outcomes: HBA1c, fasting serum total cholesterol, LDL-cholesterol, triglyceride, insulin resistance, GLP-1, AST, ALT, CAP (fibroscan), creatinine, hs-CRP, SBP and DBP at the end of 12 weeks of SB intake versus baseline.
- Conditions
- Prediabetes, Type 2 Diabetes
- Being tested
- Freeze dried whole Saskatoon berry, Freeze dried apple slice bulk
- Keywords
- Saskatoon berry, Dried apple, Fasting plasma glucose, Lipids, Insulin resistance, Inflammatory markers, Gut microbiota
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze dried whole Saskatoon berryDietary supplement
Freeze dried whole Saskatoon berry 40 g/day for 12 weeks
Freeze dried apple slice bulkDietary supplement
Freeze dried apple slice bulk in same carbohydrate amount as 40 g Saskatoon berry per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Freeze dried whole Saskatoon berry | Experimental | Freeze dried whole Saskatoon berry 40 g/day for 12 weeks Receives: 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 Receives: Dietary Supplement: Freeze dried apple slice bulk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (19)
Hemaglobin A1C (HbA1c)
Fasting blood HbA1c (%, normal range 4.0-6.0%) will be measured chemically at the baseline and the end of the intervention
Measured: 12 weeks
Total serum choleserol (TC)
Fasting TC (mM/L. normal for adults <5.2 mM/) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Low density lipoprotein-cholesterol (LDL-c)
Fasting LDL-c (mM/L, normal <2 mM/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Triglycerides (TAG)
Fasting serum TAG (mM/L, normal <1.7 mM/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
High density lipoprotein-cholesterol (HDL-c)
Fasting serum HDL-c (mM/L, normal >1.0 mM/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Apoprotein B (apoB)
Fasting serum apoB (g/L, normal <1.2 g/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Apoprotein A-I (apoA-I)
Fasting serum apoA-I (gL, normal male adults >1.07 g/L. normal female >1.22 g/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Insulin
Fasting serum insulin (pmol/L, normal <140 pmol/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is an adjusted ratio based on FPG and fasting insulin in simultaneously collected blood samples (normal <1.9) and it will be calculated for samples collected at the baseline and the end of the intervention.
Measured: 12 weeks
Glucagon-like peptide-1 (GLP-1)
Fasting serum GLP-1 (pmol/L, normal 015 pmol/L) will be measured using MSD V-Plex GLP-1 active kit at the baseline and the end of the intervention.
Measured: 12 weeks
High-sensitive C-reative protein (hs-CRP)
Fasting plasma hs-CRP (mg/L, normal <10 mg/L) will be measured using ELISA kit at the baseline and the end of the intervention.
Measured: 12 weeks
Aspartate transaminase (AST)
Serum AST (U/L, normal range 10-32 U/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Alanine transaminase (ALT)
Serum ALT (U/L, normal range: male < 30 U/L, female < 25 U/L) will be measured chemically at the baseline and the end of the intervention.
Measured: 12 weeks
Conditioned Attenuation Paramer (CAP) from fibroscan
CAP (dB/m, normal range <238 dB/m) will be assessed <3 months after the end of the dietary intervention compared to that measured <6 months before the start of the intervention in Hepatology Clinic.
Measured: <12 months
Systolic blood pressure (SBP)
SBP (mmHg, normal <130 mmHg) will be measured at sitting position after >5 min of rest at baseline and at the end of intervention
Measured: 12 weeks
Diastolic blood pressure (DBP)
DBP (mmHg, normal range 60-80 mmHg) will be measured at sitting position after >5 min of rest at baseline and at the end of intervention
Measured: 12 weeks
Body weights
Body weights (kg) will be measured will be measured at baseline and at the end of intervention. Body weight will be used to calculate body mass index (BMI) using height of the same participant. The normal range of BMI is 18.5-24.9 kg/M2.
Measured: 12 weeks
Gut microbiome
Gut microbiome will be analysed in fecal samples collected at baseline and at the end of intervention at Dalhousie University to determine bacterial composition, abundance and relationship with metabolism. The normal range of human gut microbiome currently does not available.
Measured: 12 weeks
Fecal short chain fatty acids (SCFA)
Fecal SCFA will be analysed in fecal samples collected at baseline and at the end of intervention by Microbiome Insight Inc. to determine fecal SCFA composition, abundances and relationship with metabolism. The normal range of human fecal SCFA currently does not available.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Apr 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354386
- Sponsor's protocol ID
- HS26882 (B2025:027)
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' privacy and confidential information would not be disclosed.
Publications
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.
PubMed 32230955Zhao 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.
PubMed 36332818Zhao 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.
PubMed 34004342Zhao 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.
PubMed 34442633Huang 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.
PubMed 32824001Zhao 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.
PubMed 31078906Zhao 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.
PubMed 26260864Zhao 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.
PubMed 24925752
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researcher-blinded Randomized Controlled Trial of the Effects of Dried Whole Fruits on Glucose and Lipid Levels in Prediabetic and Type 2 Diabetic Individuals
- ClinicalTrials.gov ID
- NCT07354386
- Acronym / sponsor ID
- HS26882 (B2025:027)
- Conditions
- Prediabetes, Type 2 Diabetes
- Keywords
- Saskatoon berry, Dried apple, Fasting plasma glucose, Lipids, Insulin resistance, Inflammatory markers, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subject recruitment: Untreated prediabetes or new type 2 diabetic (T2D) patients (males and females, 18-74 years of age) and willing to sign an informed consent will be recruited from community clinics in Winnipeg, Endocrine or Hepatologic Clinics in University of Manitoba and Rossmere Medical Centre in Winnipeg by posters. Exclusion criteria include: 1) candidates have a history of myocardial infarction, stroke or chronic kidney disease; 2) participants treated with hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a month. Candidates will be invited to read and voluntarily sign an informed consent approved by Research Ethics Board in University of Manitoba. Recruitment goal: n = 92 (80 + 15% expected drop-off).
Randomization: Eligible participant will be enrolled and randomization into two groups through a web randomization tool. Randomized ID will be obtained for each participant used in files or labels on packages of dried fruits.
Dietary supplements: Freeze dried Saskatoon berry (SB) have been obtained from Prairie Berries Inc. The berries were freshly frozen and no 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. Control dietary supplement will be dried apple slice bulk without supplementation (Vancouver Freeze Dry, Langley, BC). Two types of dietary supplements will be weighed and packed: 1) 40 g of dried whole SB/bag; 2) dried apple slice bulk in a weight containing carbohydrate equivalent to 40 g of SB/bag). Non-transparent bags labeled only with randomization ID will be used for the package of the fruits.
Duration of the dietary regimen: 12 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): Blood withdrawal at Health Sciences Center (HSC) in Winnipeg after an overnight fasting. Fasting plasma glucose, insulin, HbA1C, lipid profile, liver enzymes (alanine transaminase or ALT, aspartate transaminase or AST), apoB, apoA-I, and creatinine will be analyzed in Clinical Chemistry in HSC. An extra 3 ml of blood withdraw in serum tube. The serum will be temporarily stored in Clinical Chemistry for measuring insulin, GLP-1 and high-sensitive C-reactive protein (hs-CRP) by Investigator's group.
Visit 3 (at 6 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 12 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. Blood samples will be collected for biochemical analyses as descried in Visit 2. Same amount blood will be collected for serum temporarily stored for the analysis of GLP-1 and hs-CRP. 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. 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 shipment to analysis in Integrate Microbiome Resource at Dalhousie University.
Data collection and analysis: Biochemical, physical exam, questionnaires, surveys, results from gut microbiota and SCFAs will be collected and inputted to password protected computers of PI and Project Coordinator with only ID but not names or other identifiable information. Data will be analyzed using standards statistical software and tools.
Expected outcomes Primary outcome: Fasting plasma glucose at the end of 12 weeks of SB intake compared to baseline.
Secondary outcomes: HBA1c, fasting serum total cholesterol, LDL-cholesterol, triglyceride, insulin resistance, GLP-1, AST, ALT, CAP (fibroscan), creatinine, hs-CRP, SBP and DBP at the end of 12 weeks of SB intake versus baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze dried whole Saskatoon berry | Experimental | Dietary Supplement: Freeze dried whole Saskatoon berryFreeze dried whole Saskatoon berry 40 g/day for 12 weeks |
| Freeze dried apple slize bulk | Placebo comparator | Dietary Supplement: Freeze dried apple slice bulkFreeze dried apple slice bulk in the same carbohydrate amount as in 40 g of Saskatoon berry per day for 12 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze dried whole Saskatoon berryFreeze dried whole Saskatoon berry 40 g/day for 12 weeks | Dietary supplement | Freeze dried whole Saskatoon berry |
| Freeze dried apple slice bulkFreeze dried apple slice bulk in same carbohydrate amount as 40 g Saskatoon berry per day for 12 weeks | Dietary supplement | Freeze dried apple slize bulk |
Primary outcome
Fasting plasma glucose (FPG)
Time frame: 12 weeks
FPG (mM/L, normal range 3.6-6.1 mM/L) will be measured chemically at baseline and end of the intervention
19 secondary outcomes
Hemaglobin A1C (HbA1c)
Time frame: 12 weeks
Total serum choleserol (TC)
Time frame: 12 weeks
Low density lipoprotein-cholesterol (LDL-c)
Time frame: 12 weeks
Triglycerides (TAG)
Time frame: 12 weeks
High density lipoprotein-cholesterol (HDL-c)
Time frame: 12 weeks
Apoprotein B (apoB)
Time frame: 12 weeks
Apoprotein A-I (apoA-I)
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 weeks
Glucagon-like peptide-1 (GLP-1)
Time frame: 12 weeks
High-sensitive C-reative protein (hs-CRP)
Time frame: 12 weeks
Aspartate transaminase (AST)
Time frame: 12 weeks
Alanine transaminase (ALT)
Time frame: 12 weeks
Conditioned Attenuation Paramer (CAP) from fibroscan
Time frame: <12 months
Systolic blood pressure (SBP)
Time frame: 12 weeks
Diastolic blood pressure (DBP)
Time frame: 12 weeks
Body weights
Time frame: 12 weeks
Gut microbiome
Time frame: 12 weeks
Fecal short chain fatty acids (SCFA)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 32230955du 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.
- Background: PubMed 36332818Zhao 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.
- Background: PubMed 34004342Zhao 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.
- Background: PubMed 34442633Zhao 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.
- Background: PubMed 32824001Huang 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.
- Background: PubMed 31078906Zhao 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.
- Background: PubMed 26260864Zhao 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.
- Background: PubMed 24925752Zhao 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.
- Individual participant dataSharing planned: No. Participants' privacy and confidential information would not be disclosed.
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Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze dried whole Saskatoon berry and Freeze dried apple slice bulk in people with Prediabetes and Type 2 Diabetes, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (FPG) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354386, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.