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Clinical Trials/NCT02458027
NCT02458027CompletedNot Applicable

Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2 - Are Acute Effects of Hemp Protein on Blood Glucose and Appetite Insulin-dependent?

University of Manitoba2 sites in 1 country15 target enrollmentStarted: July 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Plasma Glucose and Insulin Concentrations

Study Overview

Brief Summary

The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Detailed Description

The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control. The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

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

Inclusion Criteria

  • Normoglycemic (<5.6 mmol/L)
  • Body mass index (BMI) of 18.5-29.9 kg/m2.

Exclusion Criteria

  • Restrained eaters
  • Regularly skip breakfast
  • Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Outcomes

Primary Outcomes

Plasma Glucose and Insulin Concentrations

Time Frame: 0-200 minutes

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. (Composite measure)

Food Intake

Time Frame: 0-200 minutes

Measured by fixed energy meal.

Blood Pressure

Time Frame: 0-200 minutes

Measured by automated bood pressure cuff.

Appetite

Time Frame: 0-200 minutes

Measured by VAS Questionnaire.

Secondary Outcomes

  • Palatability of Treatments and Meal(5-80 minutes)
  • Physical Comfort(0-200 minutes)
  • Energy/Fatigue(0-200 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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