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CompletedNCT02571114Updated Sep 29, 2016

Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females

An interventional study of Saskatoon Berry Frozen Yogurt and Frozen Yogurt in Healthy, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-29.

Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Healthy

Keywords

  • Glycemic Responses
  • Metabolic Responses
  • Males
  • Females
03

In context

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male, or non-pregnant, non-lactating female, ≥18 and ≤35 years;
  2. 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%;
  3. Blood pressure \<140/90
  4. Body mass index (BMI) ≥20 and \<30;
  5. Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
  6. Agree not to eat Saskatoon berries or foods containing Saskatoon berries while participating in this study;
  7. Willing to comply with the protocol requirements;
  8. Willing to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Not able to consume yogurt or allergies to Saskatoon berries or ingredients in yogurt or bread;
  2. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
  3. Taking any prescribed medication in the last 3 months or supplements that affect gastrointestinal function in the last 3 months;
  4. Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
  5. Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
  6. Unable to obtain blood samples at the screening or the first study visit.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    Control 1

    white bread - 25 g available carbohydrate

    Dietary Supplement: Control 1

  • Active comparator
    Control 2

    white bread - 25 g available carbohydrate

    Dietary Supplement: Control 2

  • Sham comparator
    Frozen Yogurt

    unflavoured frozen yogurt - 25 g available carbohydrate

    Dietary Supplement: Frozen Yogurt

  • Experimental
    Saskatoon Berry Frozen Yogurt

    frozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate

    Dietary Supplement: Saskatoon Berry Frozen Yogurt

Interventions

  • Dietary supplementSaskatoon Berry Frozen Yogurt

    Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)

  • Dietary supplementFrozen Yogurt

    Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)

  • Dietary supplementControl 1

    White bread (serving size = 25 g available carbohydrate)

  • Dietary supplementControl 2

    White bread (serving size = 25 g available carbohydrate)

06

What researchers measure

Primary outcomes

  1. Serum glucose

    glucometer readings of serum glucose at intervals after consumption of study foods

    Time frame: 180 min

Secondary outcomes

  1. serum insulin

    serum insulin levels in response to consumption of study foods

    Time frame: 180 min

  2. metabolomics

    mass spectrometry analysis of serum and urine before and after consumption of study foods

    Time frame: 180 min

07

Study locations

1 site
  • St. Boniface Hospital, Asper Clinical Research Institute
    Winnipeg, Manitoba R2H 2A6, Canada
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02571114
Lead sponsor
University of Manitoba
Responsible party
Sponsor
First posted
Oct 8, 2015
Start date
Oct 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 29, 2016

Study contacts

Carla G Taylor, PhD
principal investigator · St. Boniface Hospital, Asper Clinical Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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