A FINEH Protein Trial - Part 1

University of Manitoba

Status: Completed

Conditions: Obesity Prevention; Diabetes Prevention

Treatments: Other: Control; Other: Soybean shake; Other: Hemp shake

Study type: Interventional

Funder types: Other

Identifiers

NCT02366598

B2014:115

Details and patient eligibility

About

The objectives of this trial are to assess the health benefits of acute hemp protein consumption compared to soybean protein and a non-protein control on: 1) blood glucose, appetite and blood pressure for one hour following consumption, 2) food intake at an ad libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure following the ad libitum meal to determine the "second meal effect" of hemp protein.

Enrollment: 31 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normoglycemic (<5.6 mmol/L)
• Body mass index (BMI) of 18.5-29.9 kg/m2 Participants will be excluded if they regularly skip breakfast, smoke, or consuming medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Exclusion criteria

• Restrained eaters
• Regularly skip breakfast
• Smokers
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 5 patient groups, including a placebo group

20g Hemp protein shake

Experimental group

Description:

Hemp protein shake, 20 grams, given once at beginning of acute trial

Treatment:

Other: Hemp shake

40 g hemp protein shake

Experimental group

Description:

Hemp protein shake, 40 grams, given once, at beginning of acute trial

Treatment:

Other: Hemp shake

20 g Soybean protein shake

Active Comparator group

Description:

Soybean protein shake, 20 grams, given once, at beginning of acute trial

Treatment:

Other: Soybean shake

40 g Soybean protein shake

Experimental group

Description:

Soybean protein shake, 40 grams, given once, at beginning of acute trial

Treatment:

Other: Soybean shake

Control shake

Placebo Comparator group

Description:

non-protein control shake, given once, at beginning of acute trial

Treatment:

Other: Control