- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928688
Assessment of Glycemic Index for Dried Saskatoon Berries and Powder in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
I. Research Objective: This study aims to evaluate the GI of Saskatoon berry powder and whole fruit in healthy individuals.
II. Methodology:
Study Design
- Type: Randomized, open-label study.
- Duration: Approximately 4 weeks for each participant.
- Setting: Clinical nutrition laboratory.
Participant Recruitment:
Following approval from the University of Manitoba Research Ethics Board, we will distribute recruitment materials across the university campus. Interested individuals may contact the research coordinator to express interest in participation.
Target enrollment: 10-20 participants
Eligibility Requirements:
- Individuals in good health (males and females)
- Between 18 and 74 years of age
- Body Mass Index (BMI) within the range of 18.5-29.9 kg/m²
- Free from diabetes, hyperlipidemia, and hypertension
- Must not be taking medications for diabetes, cholesterol, or blood pressure management.
Required Resources
- Saskatoon berry powder (Prairie Berry Inc.)
- Whole Saskatoon berries (Prairie Berry Inc.)
- Control substance: 25g glucose drink
- Glucose monitoring instruments
- Water (250ml) for powder administration Protocol Overview Visit #1: Initial Session: Research consent The research coordinator will conduct informed consent procedures at an agreed-upon location.
Initial Assessment:
- Blood pressure measurement
- Heart rate monitoring
- Anthropometric measurements Visit #2: Primary Testing Session
Preparation Guidelines:
- Fasting period: 10-14 hours overnight
- Session start: 9:00 AM
- Testing Protocol:
The participant will receive either Saskatoon berry powder (25g carbohydrate equivalent) with 250ml of water (consumption within 10 minutes), or whole Saskatoon berries (25g carbohydrate equivalent, consumption within 20 minutes) or glucose drink (25 g carbohydrate, consumption with in 10 min).
Blood glucose monitoring schedule:
Initial reading (0 min) 15 minutes post-consumption 30 minutes post-consumption 45 minutes post-consumption 60 minutes post-consumption 90 minutes post-consumption 120 minutes post-consumption Visit #3: Reference Food Assessment Participants will undergo an identical protocol with oral glucose drink (25g carbohydrate equivalent) 2-7 days following the initial assessment.
Important: A minimum 48-hour washout period is required between each test (control or berry preparation).
Analytical Methods The glycemic index will be determined through analysis of blood glucose area under curve (AUC), following established protocols (Brouns et al., 2005).
- GI will be calculated as the ratio of the incremental AUC (iAUC) for SB to the iAUC for glucose drink, multiplied by 100.
- Data will be presented as mean ± standard deviation.
- Paired t-tests or equivalent non-parametric tests will be used to compare iAUC between SB and glucose drink.
- A p-value < 0.05 will be considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 3P4
- University of Manitoba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals in good health (males and females)
- Between 18 and 74 years of age
- Signed informed consent
Exclusion Criteria:
- Body Mass Index (BMI) >= 30 kg/m²
- Diabetes, hyperlipidemia, and hypertension
- Taking medications for diabetes, cholesterol, or blood pressure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SB powder
Volunteers drink 25 g of SB powder (25g carbohydrate equivalent) with 250ml water (consumption within 10 minutes)
|
After oral intake of SB powder, dried whole SB fruit or glucose drink, finger tip blood glucose will be measured 15, 30, 45, 60, 90 and 120 minutes after the consumption.
Other Names:
|
|
Experimental: Dried whole SB fruit
Volunteers intake Dried whole SB fruit (25g carbohydrate equivalent) within 20 minutes.
Participants have option to choose intake one or both SB products.
One week interval is required between the interventions.
|
After oral intake of SB powder, dried whole SB fruit or glucose drink, finger tip blood glucose will be measured 15, 30, 45, 60, 90 and 120 minutes after the consumption.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic index
Time Frame: 15-120 minutes after consumption dietary supplement
|
Glyemic index after the consumption of SB powder or dried whole SB compared to glucose drink
|
15-120 minutes after consumption dietary supplement
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS26810 (B2025:012)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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