Saskatoon Berry on Metabolism and Gut Microbiota in Healthy Subjects

Nutritional and Metabolic Diseases Clinical Trial

Official title:

Pilot Study on the Effects of Saskatoon Berry on Glucose Metabolism, Insulin Resistance and Gut Microbiota in Healthy Human Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809688
• Other study ID #: HS23500 (B2019:122)
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: October 2022
• Source: University of Manitoba
• Contact: Garry Shen, MD PhD
• Phone: 204-789-3816
• Email: garry.shen[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 powder (SBp) attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The results in antidiabetic activities of SBp have been supported by other groups in high fat fed rats. The combination of findings suggest that Saskatoon berry is good candidate of prebiotic functional food as a supplemental remedy for reducing insulin resistance, metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in human subjects. We propose to examine the effect of oral administration of freeze-dried Saskatoon berry on glucose metabolism, insulin resistance and gut microbiota in healthy adults in a pilot trial.

Description:

Subject recruitment: Healthy subjects (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, liver enzymes (alanine transaminase or ALT, aspartate transaminase or AST), creatinine, lipid profile and inflammation markers (e. x. tumor necrosis factor-alpha or TNF-alpha) will be measured as baseline. 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 an OGTT. Blood samples for insulin, liver enzymes, creatinine, lipid profile and inflammation markers will be collected from each participant. 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. Inflammation mediators 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects living in Winnipeg.

2. Willingness to sign an informed consent.

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Dietary Supplement:
• Saskatoon berry
Freeze dried Saskatoon berry (30 g) will be orally administrated daily for 10 weeks.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Diabetes Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Onset and 10 weeks after the start of dietary intervention
Primary	Glucose tolerance	75 g oral glucose tolerance test (2 h postprandial plasma glucose in mM/L)	Changes from baseline to 10 weeks after the start of dietary intervention
Primary	Gut microbiome	Stool will be collected for 16S rRNA gene sequencing in % of abundance	Changes from baseline to 10 weeks after the start of dietary intervention
Secondary	Lipid profile	total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol in mM/L	Onset and 10 weeks after the start of dietary intervention
Secondary	C-reactive protein	C-reactive protein in mg/L	Onset and 10 weeks after the start of dietary intervention
Secondary	Liver enzymes	ALT, AST in units/L	Onset and 10 weeks after the start of dietary intervention
Secondary	Body mass index accord to body weight and height	Body weight in kg, heights in cm, and body mass index in kg/M^2	Onset, 5 and 10 weeks after the start of dietary intervention
Secondary	Blood pressure	Systolic and diastolic blood pressure in mmHg	Onset, 5 and 10 weeks after the start of dietary intervention
Secondary	Tumor necrosis factor-alpha	Tumor necrosis factor-alpha in pg/mL	Onset, 5 and 10 weeks after the start of dietary intervention