Saskatoon Berry on Metabolism and Gut Microbiota in Healthy Subjects

NCT04809688 | Enrolling By Invitation DMC

• 1 other identifier: HS23500 (B2019:122)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Nutritional and Metabolic Diseases

Keywords

Saskatoon berry; Glucose tolerance; Gut microbiota; Healthy subjects

Outcome Measures

Primary Outcomes (2)

• Fasting plasma glucose

  Fasting plasma glucose in mM/L

  Changes from baseline to 10 weeks after the start of dietary intervention

• Total serum cholesterol

  Fasting total cholesterol in mM/L

  Changes from baseline to 10 weeks after the start of dietary intervention

Secondary Outcomes (8)

• Lipid profile beside total cholesterol

  Onset and 10 weeks after the start of dietary intervention

• C-reactive protein

  Onset and 10 weeks after the start of dietary intervention

• Liver enzymes

  Onset and 10 weeks after the start of dietary intervention

• Body mass index accord to body weight and height

  Onset, 5 and 10 weeks after the start of dietary intervention

• Blood pressure

  Onset, 5 and 10 weeks after the start of dietary intervention

Other Outcomes (1)

• Dietary intake, physical activities

  Onset and 10 weeks after the start of dietary intervention

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm for healthy subjects using dried whole Saskatoon berry

Dietary Supplement: Saskatoon berry; Dietary Supplement: Dried Saskatoon berry

Interventions

Saskatoon berry DIETARY_SUPPLEMENT

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

Single arm

Dried Saskatoon berry DIETARY_SUPPLEMENT

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,

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects living in Winnipeg.
• Willingness to sign an informed consent.

You may not qualify if:

• \. History of myocardial infarction, stroke, hypertension, diabetes, hyperlipidemia, chronic kidney disease.
• \) Participants are taking hypoglycemic, anti-hypertensives, lipid lowering medications or antibiotics within a 1 month.

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (3)

• 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

• 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

• 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

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Officials

• Garry Shen, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gary Shen

Model Details: Healthy subject (n=20) will be enrolled in a single group for oral administration of dried Saskatoon berry as snack. Healthy subjects (n=10) will be enrolled in a single group for assessing glycemic index for dried Saskatoon berry. Prediabetes (n=20) will be randomized in two groups for dried Saskatoon berry and placebo.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: March 22, 2021
• Study Start: January 8, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)