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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Control 2; Dietary Supplement: Control 1; Dietary Supplement: Frozen Yogurt; Dietary Supplement: Saskatoon Berry Frozen Yogurt

• Registration Number: NCT02571114
• Lead Sponsor: University of Manitoba

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control 2	Control 2	white bread - 25 g available carbohydrate
Control 1	Control 1	white bread - 25 g available carbohydrate
Frozen Yogurt	Frozen Yogurt	unflavoured frozen yogurt - 25 g available carbohydrate
Saskatoon Berry Frozen Yogurt	Saskatoon Berry Frozen Yogurt	frozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate

Primary Outcome Measures

Name	Time	Method
Serum glucose	180 min	glucometer readings of serum glucose at intervals after consumption of study foods

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Boniface Hospital, Asper Clinical Research Institute; 🇨🇦 Winnipeg, Manitoba, Canada