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

University of Manitoba1 site in 1 country13 target enrollmentOctober 2015

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: University of Manitoba
Enrollment: 13
Locations: 1
Primary Endpoint: Serum glucose
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Manitoba

Responsible Party

Sponsor

Eligibility Criteria

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.