HealthyNCT02571114
Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
A study testing Saskatoon Berry Frozen Yogurt and Frozen Yogurt in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial summary
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saskatoon Berry Frozen Yogurt and Frozen Yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Jun 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, or non-pregnant, non-lactating female, ≥18 and ≤35 years;
- Normal blood lipid profile, creatinine <1.5× upper limit of normal (ULN) where the normal range is ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) <2× ULN where the normal range is ≥0.7 mg/dL and ≤1.3 mg/dL, and glycated hemoglobin <6%;
- Blood pressure <140/90
- Body mass index (BMI) ≥20 and <30;
- Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
- Agree not to eat Saskatoon berries or foods containing Saskatoon berries while participating in this study;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
Who cannot join
- Not able to consume yogurt or allergies to Saskatoon berries or ingredients in yogurt or bread;
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Taking any prescribed medication in the last 3 months or supplements that affect gastrointestinal function in the last 3 months;
- Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
- Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
- Unable to obtain blood samples at the screening or the first study visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface Hospital, Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Randomized, Controlled Study to Examine the Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females.
Read the detailed description
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females. Eligible participants will be asked to attend 4 in-person clinic visits for comparative testing of the frozen yogurt and frozen yogurt containing Saskatoon berry powder versus white bread. Separate visits for screening and for a fasting blood sample will also be requested (total of 6 visits).
- Conditions
- Healthy
- Being tested
- Saskatoon Berry Frozen Yogurt, Frozen Yogurt, Control 1, Control 2
- Keywords
- Glycemic Responses, Metabolic Responses, Males, Females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saskatoon Berry Frozen YogurtDietary supplement
Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)
Frozen YogurtDietary supplement
Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)
Control 1Dietary supplement
White bread (serving size = 25 g available carbohydrate)
Control 2Dietary supplement
White bread (serving size = 25 g available carbohydrate)
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Active comparator | white bread - 25 g available carbohydrate Receives: Dietary Supplement: Control 1 |
| Control 2 | Active comparator | white bread - 25 g available carbohydrate Receives: Dietary Supplement: Control 2 |
| Frozen Yogurt | Sham comparator | unflavoured frozen yogurt - 25 g available carbohydrate Receives: Dietary Supplement: Frozen Yogurt |
| Saskatoon Berry Frozen Yogurt | Experimental | frozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate Receives: Dietary Supplement: Saskatoon Berry Frozen Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose
glucometer readings of serum glucose at intervals after consumption of study foods
Measured: 180 min
Secondary outcomes (2)
serum insulin
serum insulin levels in response to consumption of study foods
Measured: 180 min
metabolomics
mass spectrometry analysis of serum and urine before and after consumption of study foods
Measured: 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla G Taylor, PhD, Principal investigator, St. Boniface Hospital Asper Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571114
- Sponsor's protocol ID
- B2014:121
- Status last verified
- Sep 2016
- First submitted
- 6 Oct 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.
PubMed 33380172
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Examine the Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
- ClinicalTrials.gov ID
- NCT02571114
- Acronym / sponsor ID
- B2014:121
- Conditions
- Healthy
- Keywords
- Glycemic Responses, Metabolic Responses, Males, Females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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.
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females.
Detailed description
A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females. Eligible participants will be asked to attend 4 in-person clinic visits for comparative testing of the frozen yogurt and frozen yogurt containing Saskatoon berry powder versus white bread. Separate visits for screening and for a fasting blood sample will also be requested (total of 6 visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Active comparator | Dietary Supplement: Control 1white bread - 25 g available carbohydrate |
| Control 2 | Active comparator | Dietary Supplement: Control 2white bread - 25 g available carbohydrate |
| Frozen Yogurt | Sham comparator | Dietary Supplement: Frozen Yogurtunflavoured frozen yogurt - 25 g available carbohydrate |
| Saskatoon Berry Frozen Yogurt | Experimental | Dietary Supplement: Saskatoon Berry Frozen Yogurtfrozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male, or non-pregnant, non-lactating female, ≥18 and ≤35 years;
- Normal blood lipid profile, creatinine <1.5× upper limit of normal (ULN) where the normal range is ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) <2× ULN where the normal range is ≥0.7 mg/dL and ≤1.3 mg/dL, and glycated hemoglobin <6%;
- Blood pressure <140/90
- Body mass index (BMI) ≥20 and <30;
- Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
Key exclusion criteria (6 listed)
- Not able to consume yogurt or allergies to Saskatoon berries or ingredients in yogurt or bread;
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Taking any prescribed medication in the last 3 months or supplements that affect gastrointestinal function in the last 3 months;
- Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
- Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
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 Frozen YogurtFrozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate) | Dietary supplement | Saskatoon Berry Frozen Yogurt |
| Frozen YogurtUnflavoured frozen yogurt (serving size = 25 g available carbohydrate) | Dietary supplement | Frozen Yogurt |
| Control 1White bread (serving size = 25 g available carbohydrate) | Dietary supplement | Control 1 |
| Control 2White bread (serving size = 25 g available carbohydrate) | Dietary supplement | Control 2 |
Primary outcome
Serum glucose
Time frame: 180 min
glucometer readings of serum glucose at intervals after consumption of study foods
2 secondary outcomes
serum insulin
Time frame: 180 min
metabolomics
Time frame: 180 min
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 29 Sep 2016.
- Derived from this study: PubMed 33380172Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.
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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.
Carla G Taylor, PhD principal investigator
St. Boniface Hospital Asper Clinical Research Institute
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 Frozen Yogurt and Frozen Yogurt in people with Healthy, 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 8 inclusion and 6 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 29 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Serum glucose (time frame: 180 min). 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 NCT02571114, which also lists 1 linked publication.
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 29 Sep 2016.