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

NCT ID: NCT02571114

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control 1

white bread - 25 g available carbohydrate

Group Type: ACTIVE_COMPARATOR

Control 1

Intervention Type: DIETARY_SUPPLEMENT

White bread (serving size = 25 g available carbohydrate)

Control 2

white bread - 25 g available carbohydrate

Group Type: ACTIVE_COMPARATOR

Control 2

Intervention Type: DIETARY_SUPPLEMENT

White bread (serving size = 25 g available carbohydrate)

Frozen Yogurt

unflavoured frozen yogurt - 25 g available carbohydrate

Group Type: SHAM_COMPARATOR

Frozen Yogurt

Intervention Type: DIETARY_SUPPLEMENT

Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)

Saskatoon Berry Frozen Yogurt

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

Group Type: EXPERIMENTAL

Saskatoon Berry Frozen Yogurt

Intervention Type: DIETARY_SUPPLEMENT

Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)

Interventions

Saskatoon Berry Frozen Yogurt

Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)

Intervention Type: DIETARY_SUPPLEMENT

Frozen Yogurt

Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)

Intervention Type: DIETARY_SUPPLEMENT

Control 1

White bread (serving size = 25 g available carbohydrate)

Intervention Type: DIETARY_SUPPLEMENT

Control 2

White bread (serving size = 25 g available carbohydrate)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla G Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Boniface Hospital Asper Clinical Research Institute

Locations

St. Boniface Hospital, Asper Clinical Research Institute

Winnipeg, Manitoba, Canada

Countries

Canada

References

Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.

Reference Type: DERIVED

PMID: 33380172 (View on PubMed)

Other Identifiers

B2014:121

Identifier Type: -

Identifier Source: org_study_id