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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571114
• Other study ID #: B2014:121
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: September 27, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Saskatoon Berry Frozen Yogurt
Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)
• Frozen Yogurt
Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)
• Control 1
White bread (serving size = 25 g available carbohydrate)
• Control 2
White bread (serving size = 25 g available carbohydrate)

Locations

Country	Name	City	State
Canada	St. Boniface Hospital, Asper Clinical Research Institute	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum glucose	glucometer readings of serum glucose at intervals after consumption of study foods	180 min	No
Secondary	serum insulin	serum insulin levels in response to consumption of study foods	180 min	No
Secondary	metabolomics	mass spectrometry analysis of serum and urine before and after consumption of study foods	180 min	No