Healthy
Conditions
Keywords
Glycemic Responses, Metabolic Responses, Males, Females
Brief 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.
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).
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)
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum glucose | 180 min | glucometer readings of serum glucose at intervals after consumption of study foods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum insulin | 180 min | serum insulin levels in response to consumption of study foods |
| metabolomics | 180 min | mass spectrometry analysis of serum and urine before and after consumption of study foods |
Countries
Canada
Outcome results
None listed