Healthy Volunteers (HV)NCT06928688
Assessment of Glycemic Index for Dried Saskatoon Berries and Powder in Healthy Subjects
A study testing Saskatoon berry powder in people with Healthy Volunteers (HV), run by University of Manitoba at 1 site in Canada.
Trial summary
The glycemic index (GI) ranks carbohydrate-containing foods based on their effect on postprandial blood glucose levels. Foods or food products with lower GI values (55 or less) are absorbed more slowly, gradually increasing blood glucose and insulin levels. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Healthy Volunteers (HV)
- What is being tested?
- Saskatoon berry powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Individuals in good health (males and females)
- Between 18 and 74 years of age
- Signed informed consent
Who cannot join
- Body Mass Index (BMI) >= 30 kg/m²
- Diabetes, hyperlipidemia, and hypertension
- Taking medications for diabetes, cholesterol, or blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
The glycemic index (GI) ranks carbohydrate-containing foods based on their effect on postprandial blood glucose levels. Foods or food products with lower GI values (55 or less) are absorbed more slowly, gradually increasing blood glucose and insulin levels. Fruits are believed to have a lower GI, making them potentially beneficial for individuals seeking to manage blood sugar levels. Previous studies from our and other groups suggest that Saskatoon berry (SB) is a potential functional food for glucose management. The glycemic index (GI) of dried SB powder and whole fruit remains undetermined, limiting our ability to make precise dietary recommendations. This study aims to evaluate the GI in both whole fruit and powder forms of SB. The determination of GI on SB products allows us to provide evidence-based guidance for healthcare providers when recommending SB as a functional food for glucose control.
Read the detailed description
- 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.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- Saskatoon berry powder
- Keywords
- Postprandial glucose, Glycemic index, blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saskatoon berry powderDietary supplement
Also called Dried whole Saskatoon berry, Glucose drink as control
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.
| Study group | Role | What they receive |
|---|---|---|
| SB powder | Experimental | Volunteers drink 25 g of SB powder (25g carbohydrate equivalent) with 250ml water (consumption within 10 minutes) Receives: Dietary Supplement: Saskatoon berry powder |
| Dried whole SB fruit | Experimental | 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. Receives: Dietary Supplement: Saskatoon berry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index
Glyemic index after the consumption of SB powder or dried whole SB compared to glucose drink
Measured: 15-120 minutes after consumption dietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Mar 2025
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers (HV)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers will receive SB powder, whole dried SB fruit or glucose drink with matching carbohydrate as control with 1 week interval between any two tests.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928688
- Sponsor's protocol ID
- HS26810 (B2025:012)
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19079901Zhao 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 31078906
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Glycemic Index for Dried Saskatoon Berries and Powder in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06928688
- Acronym / sponsor ID
- HS26810 (B2025:012)
- Conditions
- Healthy Volunteers (HV)
- Keywords
- Postprandial glucose, Glycemic index, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 15 Apr 2025 (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.
The glycemic index (GI) ranks carbohydrate-containing foods based on their effect on postprandial blood glucose levels. Foods or food products with lower GI values (55 or less) are absorbed more slowly, gradually increasing blood glucose and insulin levels. Fruits are believed to have a lower GI, making them potentially beneficial for individuals seeking to manage blood sugar levels. Previous studies from our and other groups suggest that Saskatoon berry (SB) is a potential functional food for glucose management. The glycemic index (GI) of dried SB powder and whole fruit remains undetermined, limiting our ability to make precise dietary recommendations. This study aims to evaluate the GI in both whole fruit and powder forms of SB. The determination of GI on SB products allows us to provide evidence-based guidance for healthcare providers when recommending SB as a functional food for glucose control.
Detailed description
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Volunteers will receive SB powder, whole dried SB fruit or glucose drink with matching carbohydrate as control with 1 week interval between any two tests.
| Arm | Type | Receives |
|---|---|---|
| SB powder | Experimental | Dietary Supplement: Saskatoon berry powderVolunteers drink 25 g of SB powder (25g carbohydrate equivalent) with 250ml water (consumption within 10 minutes) |
| Dried whole SB fruit | Experimental | Dietary Supplement: Saskatoon berry powderVolunteers 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals in good health (males and females)
- Between 18 and 74 years of age
- Signed informed consent
Key exclusion criteria (3 listed)
- Body Mass Index (BMI) >= 30 kg/m²
- Diabetes, hyperlipidemia, and hypertension
- Taking medications for diabetes, cholesterol, or blood pressure
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 |
|---|---|---|
| Saskatoon berry powderAlso: Dried whole Saskatoon berry, Glucose drink as controlAfter 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. | Dietary supplement | Dried whole SB fruit, SB powder |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Results publication: PubMed 19079901Brouns 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.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Saskatoon berry powder in people with Healthy Volunteers (HV), 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic index (time frame: 15-120 minutes after consumption dietary supplement). 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 NCT06928688, which also lists 2 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 8 Jan 2026.