Clinical trial NCT02571114: Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glycemic Responses
Metabolic Responses
Males
Females
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Serum glucose
timeFrame: 180 min
Secondary outcomes:
measure: serum insulin
timeFrame: 180 min
measure: metabolomics
timeFrame: 180 min
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital, Asper Clinical Research Institute
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital Asper Clinical Research Institute
name: Carla G Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.