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Clinical Trials/NCT02385890
NCT02385890CompletedNot Applicable

Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 3

University of Manitoba2 sites in 1 country30 target enrollmentStarted: October 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Plasma Glucose and Insulin Concentrations

Study Overview

Brief Summary

The objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

The investigators hypothesize that bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg)
  • BMI of 18.5-29.9 kg/m2

Exclusion Criteria

  • Restrained eaters
  • Regularly skip breakfast
  • Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
  • Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
  • Those unable to walk for an hour continuously

Outcomes

Primary Outcomes

Plasma Glucose and Insulin Concentrations

Time Frame: 0-200

Measured in blood using intravenous catheter at 12 time points used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits

Food Intake

Time Frame: at 120 min

Ad-libitum meal. Food consumed measured by weight

Subjective Appetite

Time Frame: 0-200 min

Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)

Secondary Outcomes

  • Palatability of meal(at 140 mins)
  • Physical comfort(0 - 200 min)
  • Energy/fatigue measured by VAS questionnaire(0 - 200 mins)
  • Palatability of treatments(at 5 mins)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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