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

University of Manitoba

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Saskatoon Berry Frozen Yogurt; Dietary Supplement: Frozen Yogurt; Dietary Supplement: Control 2; Dietary Supplement: Control 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02571114

B2014:121

Details and patient eligibility

About

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.

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 4 patient groups

Control 1

Active Comparator group

Description:

white bread - 25 g available carbohydrate

Treatment:

Dietary Supplement: Control 1

Control 2

Active Comparator group

Description:

white bread - 25 g available carbohydrate

Treatment:

Dietary Supplement: Control 2

Frozen Yogurt

Sham Comparator group

Description:

unflavoured frozen yogurt - 25 g available carbohydrate

Treatment:

Dietary Supplement: Frozen Yogurt

Saskatoon Berry Frozen Yogurt

Experimental group

Description:

frozen yogurt containing powder prepared from Saskatoon berries - 25 g available carbohydrate

Treatment:

Dietary Supplement: Saskatoon Berry Frozen Yogurt