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Completed

NCT Number: NCT02571114

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital, Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Saskatoon Berry Frozen Yogurt

Dietary Supplement

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

Frozen Yogurt

Dietary Supplement

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

Control 1

Dietary Supplement

White bread (serving size = 25 g available carbohydrate)

Control 2

Dietary Supplement

White bread (serving size = 25 g available carbohydrate)

Primary outcomes

  1. Serum glucose

    Time frame: 180 min

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

Secondary outcomes

  1. serum insulin

    Time frame: 180 min

    serum insulin levels in response to consumption of study foods

  2. metabolomics

    Time frame: 180 min

    mass spectrometry analysis of serum and urine before and after consumption of study foods

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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