Saskatoon Berry for Metabolism Enhancement

Overseen By Garry Shen, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Hypoglycemics, Antihypertensives, Lipid-lowering, Antibiotics

Disqualifiers: Myocardial infarction, Stroke, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants not be taking hypoglycemic, anti-hypertensive, lipid-lowering medications, or antibiotics within one month before joining.

What data supports the effectiveness of the treatment Saskatoon berry for metabolism enhancement?

Research shows that Saskatoon berry can help improve metabolism by regulating glucose levels, reducing inflammation, and improving heart and liver health in animal studies. It has been found to normalize body weight, improve glucose tolerance, and decrease blood pressure, suggesting potential benefits for metabolic health. ^{1 2 3 4 5}

Is Saskatoon berry safe for human consumption?

Research on Saskatoon berries, also known as Amelanchier alnifolia, suggests they contain beneficial compounds like flavonoids and antioxidants, which have shown positive health effects in animal studies. While these studies indicate potential health benefits, specific safety data for human consumption is not directly available from the provided research. ^{1 3 6 7 8}

How does Saskatoon berry treatment enhance metabolism differently from other treatments?

Saskatoon berry treatment is unique because it contains high levels of antioxidants like anthocyanins and flavonols, which help regulate glucose metabolism and improve heart and liver health. Unlike other treatments, it also addresses gut health by reducing inflammation and correcting gut microbiota imbalances, making it a comprehensive approach to enhancing metabolism. ^{1 2 6 7 9}

What is the purpose of this trial?

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.

Research Team

Garry Shen, MD, PhD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for healthy individuals living in Winnipeg who are willing to sign an informed consent. It's not open to those taking hypoglycemic, anti-hypertensive or lipid-lowering medications, antibiotics within the last month, or with a history of serious metabolic diseases.

Inclusion Criteria

Healthy subjects living in Winnipeg.

Willingness to sign an informed consent.

Exclusion Criteria

I have a history of heart attack, stroke, high blood pressure, diabetes, high cholesterol, or kidney disease.

I have been taking medication for diabetes, high blood pressure, cholesterol, or antibiotics in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including OGTT, insulin, liver enzymes, creatinine, lipid profile, and inflammation markers

<1 week

1 visit (in-person)

Treatment

Participants receive 30 g/day of freeze-dried Saskatoon berry for 10 weeks

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in glucose metabolism, insulin resistance, and gut microbiota

4 weeks

Treatment Details

Interventions

• Saskatoon berry

Trial Overview The study investigates the effects of freeze-dried Saskatoon berry on glucose metabolism, insulin resistance and gut microbiota in healthy adults. This pilot trial aims to explore if this berry can help manage or prevent type 2 diabetes and metabolic syndrome.

Participant Groups

Group I: Single arm Experimental Treatment 2 Interventions

Single arm for healthy subjects using dried whole Saskatoon berry

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Health Sciences Centre Foundation, Manitoba

Collaborator

Trials

17

Recruited

9,500+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Findings from Research

In a study with male Wistar rats, adding Saskatoon berry powder to a high-carbohydrate, high-fat diet for 8 weeks significantly improved symptoms of diet-induced metabolic syndrome, including normalizing body weight, reducing visceral fat, and lowering blood pressure.

Saskatoon berry appears to enhance metabolic health by regulating key metabolic processes such as glycolysis and gluconeogenesis, as indicated by changes in liver enzyme expression and improved glucose tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saskatoon Berry Amelanchier alnifolia Regulates Glucose Metabolism and Improves Cardiovascular and Liver Signs of Diet-Induced Metabolic Syndrome in Rats. du Preez, R., Wanyonyi, S., Mouatt, P., et al.[2021]

Supplementation with freeze-dried Saskatoon berry powder (SBp) in mice on a high fat-high sucrose diet significantly reduced glucose levels, inflammatory markers, and gut microbiota imbalances, indicating its potential as a therapeutic intervention for insulin resistance.

The study found that doses of SBp as low as 1% were effective in improving metabolic health, with greater doses leading to more pronounced benefits, suggesting a dose-response relationship in mitigating diet-induced disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Responses Relationship in Glucose Lowering and Gut Dysbiosis to Saskatoon Berry Powder Supplementation in High Fat-High Sucrose Diet-Induced Insulin Resistant Mice. Zhao, R., Huang, F., Shen, GX.[2021]

Saskatoon berry powder (SBp) significantly reduced body weight gain and improved metabolic and inflammatory markers in diet-induced obese mice over a 15-week period, indicating its potential as a dietary intervention for obesity-related disorders.

The study found that SBp altered the gut microbiota composition, specifically lowering the Firmicutes/Bacteroidetes ratio, which is associated with improved metabolic health and reduced inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Saskatoon berry powder on insulin resistance and relationship with intestinal microbiota in high fat-high sucrose diet-induced obese mice. Zhao, R., Khafipour, E., Sepehri, S., et al.[2020]

Five species of wild Alaskan berries were found to contain bioactive compounds that can help reduce metabolic disorders, with R. spectabilis significantly increasing preadipocyte factor 1 expression by 182%.

Extracts from these berries reduced serum glucose levels in mice by up to 45%, highlighting their potential as a natural treatment for obesity and diabetes, while also emphasizing the importance of monitoring these resources as climate change affects their availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alaskan wild berry resources and human health under the cloud of climate change. Kellogg, J., Wang, J., Flint, C., et al.[2021]

In a study involving Hannover Sprague-Dawley rats with reno-cardiac disease, a diet enriched with Saskatoon berry (SKB) for 8 weeks did not reduce kidney weight or blood pressure but did help mitigate cardiac remodeling and lower oxidative stress markers.

The SKB diet showed potential cardioprotective properties, suggesting that its antioxidant content may be beneficial in preventing heart-related issues in conditions like polycystic kidney disease, although further human studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saskatoon berry supplementation prevents cardiac remodeling without improving renal disease in an animal model of reno-cardiac syndrome. Raj, P., Louis, XL., Yu, L., et al.[2021]

A study of four Saskatoon berry genotypes identified 48 bioactive compounds, including various polyphenols, carotenoids, and tocopherols, which are known for their health benefits.

Among the genotypes, the Polish breeding clone no. 5/6 had significantly lower levels of beneficial compounds and antioxidant activity compared to the other three genotypes, suggesting that the latter may be more valuable for health-related applications and fruit production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The composition of bioactive compounds and antioxidant activity of Saskatoon berry (Amelanchier alnifolia Nutt.) genotypes grown in central Poland. Lachowicz, S., Oszmiański, J., Pluta, S.[2018]

Saskatoon berries are rich in flavonoids, particularly flavonols like quercetin and rutin, which are powerful antioxidants contributing to their health benefits.

The high flavonoid content in Saskatoon berries is linked to various health-promoting effects, including anti-inflammatory, antidiabetic, and chemo-protective properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavonoid profile of Saskatoon berries (Amelanchier alnifolia Nutt.) and their health promoting effects. Juríková, T., Balla, S., Sochor, J., et al.[2021]

High consumption of berries, particularly bilberries and saskatoon berries, is associated with a reduced risk of cardiovascular diseases and other health issues due to their rich content of bioactive compounds like flavonoids and anthocyanins.

Recent studies suggest that these berries may improve cardiovascular risk factors, especially dyslipidemia, which is a key contributor to the development of atherosclerosis and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phytonutrients of bilberry fruit and saskatoon berry in the prevention and treatment of dyslipidemia. Kopčeková, J., Mrázová, J.[2022]

Wild berries from the Pacific Northwest, such as huckleberries and black elderberries, have high levels of beneficial polyphenols, particularly anthocyanins, which are linked to health benefits like antioxidant properties.

The Oregon grape stands out with over 1 gram of polyphenols per 100 grams and a diverse range of anthocyanin classes, suggesting it could be a valuable addition to diets for its nutritional and health-promoting potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyphenolic profiles of a variety of wild berries from the Pacific Northwest region of North America. Higbee, J., Brownmiller, C., Solverson, P., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Saskatoon Berry Amelanchier alnifolia Regulates Glucose Metabolism and Improves Cardiovascular and Liver Signs of Diet-Induced Metabolic Syndrome in Rats. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Responses Relationship in Glucose Lowering and Gut Dysbiosis to Saskatoon Berry Powder Supplementation in High Fat-High Sucrose Diet-Induced Insulin Resistant Mice. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Saskatoon berry powder on insulin resistance and relationship with intestinal microbiota in high fat-high sucrose diet-induced obese mice. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Alaskan wild berry resources and human health under the cloud of climate change. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Saskatoon berry supplementation prevents cardiac remodeling without improving renal disease in an animal model of reno-cardiac syndrome. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The composition of bioactive compounds and antioxidant activity of Saskatoon berry (Amelanchier alnifolia Nutt.) genotypes grown in central Poland. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Flavonoid profile of Saskatoon berries (Amelanchier alnifolia Nutt.) and their health promoting effects. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Phytonutrients of bilberry fruit and saskatoon berry in the prevention and treatment of dyslipidemia. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Polyphenolic profiles of a variety of wild berries from the Pacific Northwest region of North America. [2023]