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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Controlled Study to Examine the Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Saskatoon Berry Frozen Yogurt
* Dietary Supplement: Frozen Yogurt
* Dietary Supplement: Control 1
* Dietary Supplement: Control 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control 1<br>white bread - 25 g available carbohydrate | Dietary Supplement: Control 1<br>* White bread (serving size = 25 g available carbohydrate)<br>|
| Active Comparator: Control 2<br>white bread - 25 g available carbohydrate | Dietary Supplement: Control 2<br>* White bread (serving size = 25 g available carbohydrate)<br>|
| Sham Comparator: Frozen Yogurt<br>unflavoured frozen yogurt - 25 g available carbohydrate | Dietary Supplement: Frozen Yogurt<br>* Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)<br>|
| Experimental: Saskatoon Berry Frozen Yogurt<br>frozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate | Dietary Supplement: Saskatoon Berry Frozen Yogurt<br>* Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glucose | glucometer readings of serum glucose at intervals after consumption of study foods | 180 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum insulin | serum insulin levels in response to consumption of study foods | 180 min | 
| metabolomics | mass spectrometry analysis of serum and urine before and after consumption of study foods | 180 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Responses, Metabolic Responses, Males, Females