Diabetes PreventionNCT02366598
A FINEH Protein Trial - Part 1
A study testing Hemp shake and Soybean shake in people with Diabetes Prevention and Obesity Prevention, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- Hemp shake and Soybean shake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 1 - Acute Effects of Hemp Protein on Blood Glucose, Appetite, Blood Pressure and Food Intake.
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.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- Hemp shake, Soybean shake, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp shakeOther
Hemp protein shake
Soybean shakeOther
Soybean protein shake
ControlOther
Non-protein shake
| Study group | Role | What they receive |
|---|---|---|
| 20g Hemp protein shake | Experimental | Hemp protein shake, 20 grams, given once at beginning of acute trial Receives: Other: Hemp shake |
| 40 g hemp protein shake | Experimental | Hemp protein shake, 40 grams, given once, at beginning of acute trial Receives: Other: Hemp shake |
| 20 g Soybean protein shake | Active comparator | Soybean protein shake, 20 grams, given once, at beginning of acute trial Receives: Other: Soybean shake |
| 40 g Soybean protein shake | Experimental | Soybean protein shake, 40 grams, given once, at beginning of acute trial Receives: Other: Soybean shake |
| Control shake | Placebo comparator | non-protein control shake, given once, at beginning of acute trial Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration
Measured in blood by glucometer
Measured: 0-200 min
Appetite
Measured by VAS Questionnaire
Measured: 0-200 min
Food intake
Ad-libitum meal
Measured: 0-200 min
Blood pressure
Measured by automated bood pressure cuff
Measured: 0-200 min
Secondary outcomes (3)
Palatability of treatments and meal
Measured by VAS questionnaire
Measured: 5 -80 minutes
Physical comfort
Measured by VAS questionnaire
Measured: 0 - 200 min
Energy/fatigue
Measured by VAS questionnaire
Measured: 0 - 200 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Harvest
- Responsible party
- Sponsor
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366598
- Sponsor's protocol ID
- B2014:115
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2014
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 1 - Acute Effects of Hemp Protein on Blood Glucose, Appetite, Blood Pressure and Food Intake.
- ClinicalTrials.gov ID
- NCT02366598
- Acronym / sponsor ID
- B2014:115
- Conditions
- Diabetes Prevention, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Harvest
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 20g Hemp protein shake | Experimental | Other: Hemp shakeHemp protein shake, 20 grams, given once at beginning of acute trial |
| 40 g hemp protein shake | Experimental | Other: Hemp shakeHemp protein shake, 40 grams, given once, at beginning of acute trial |
| 20 g Soybean protein shake | Active comparator | Other: Soybean shakeSoybean protein shake, 20 grams, given once, at beginning of acute trial |
| 40 g Soybean protein shake | Experimental | Other: Soybean shakeSoybean protein shake, 40 grams, given once, at beginning of acute trial |
| Control shake | Placebo comparator | Other: Controlnon-protein control shake, given once, at beginning of acute trial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemp shakeHemp protein shake | Other | 20g Hemp protein shake, 40 g hemp protein shake |
| Soybean shakeSoybean protein shake | Other | 20 g Soybean protein shake, 40 g Soybean protein shake |
| ControlNon-protein shake | Other | Control shake |
Primary outcome
Blood glucose concentration
Time frame: 0-200 min
Measured in blood by glucometer
Appetite
Time frame: 0-200 min
Measured by VAS Questionnaire
Food intake
Time frame: 0-200 min
Ad-libitum meal
Blood pressure
Time frame: 0-200 min
Measured by automated bood pressure cuff
3 secondary outcomes
Palatability of treatments and meal
Time frame: 5 -80 minutes
Physical comfort
Time frame: 0 - 200 min
Energy/fatigue
Time frame: 0 - 200 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter JH Jones, PhD principal investigator
University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemp shake and Soybean shake in people with Diabetes Prevention and Obesity Prevention, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose concentration (time frame: 0-200 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.