NCT02571114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

October 6, 2015

Last Update Submit

September 27, 2016

Conditions

Healthy

Keywords

Glycemic ResponsesMetabolic ResponsesMalesFemales

Outcome Measures

Primary Outcomes (1)

  • Serum glucose

    glucometer readings of serum glucose at intervals after consumption of study foods

    180 min

Secondary Outcomes (2)

  • serum insulin

    180 min

  • metabolomics

    180 min

Study Arms (4)

Control 1

ACTIVE COMPARATOR

white bread - 25 g available carbohydrate

Dietary Supplement: Control 1

Control 2

ACTIVE COMPARATOR

white bread - 25 g available carbohydrate

Dietary Supplement: Control 2

Frozen Yogurt

SHAM COMPARATOR

unflavoured frozen yogurt - 25 g available carbohydrate

Dietary Supplement: Frozen Yogurt

Saskatoon Berry Frozen Yogurt

EXPERIMENTAL

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

Dietary Supplement: Saskatoon Berry Frozen Yogurt

Interventions

Saskatoon Berry Frozen YogurtDIETARY_SUPPLEMENT

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

Saskatoon Berry Frozen Yogurt
Frozen YogurtDIETARY_SUPPLEMENT

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

Frozen Yogurt
Control 1DIETARY_SUPPLEMENT

White bread (serving size = 25 g available carbohydrate)

Control 1
Control 2DIETARY_SUPPLEMENT

White bread (serving size = 25 g available carbohydrate)

Control 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital, Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33380172DERIVED

Study Officials

  • Carla G Taylor, PhD

    St. Boniface Hospital Asper Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

CA(1)