Diabetes PreventionNCT02458027
Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
A study testing Hemp Shake, Hemp 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 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… 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, Hemp and Soybean Shake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 13 Jul 2016
- 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.
Who cannot join
- Restrained eaters
- Regularly skip breakfast
- Smokers
- 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.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: 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?
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.
Read the 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.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- Hemp Shake, Hemp, Soybean Shake, Soybean, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp ShakeDietary supplement
Hemp Protein
HempDietary supplement
Hemp Protein Shake
Soybean ShakeDietary supplement
Soybean Protein
SoybeanDietary supplement
Soybean Protein Shake
ControlDietary supplement
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: Dietary Supplement: Hemp Shake |
| 40 g Hemp Protein | Experimental | Hemp protein shake, 40 grams, given once, at beginning of acute trial. Receives: Dietary Supplement: Hemp |
| 20 g Soybean Protein Shake | Active comparator | Soybean protein shake, 20 grams, given once, at beginning of acute trial. Receives: Dietary Supplement: Soybean Shake |
| 40 g Soybean Protein | Experimental | Soybean protein shake, 40 grams, given once, at beginning of acute trial. Receives: Dietary Supplement: Soybean |
| Control Shake | Placebo comparator | Non-protein control shake, given once, at beginning of acute trial. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose and Insulin Concentrations
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)
Measured: 0-200 minutes
Appetite
Measured by VAS Questionnaire.
Measured: 0-200 minutes
Food Intake
Measured by fixed energy meal.
Measured: 0-200 minutes
Blood Pressure
Measured by automated bood pressure cuff.
Measured: 0-200 minutes
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 minutes
Energy/Fatigue
Measured by VAS Questionnaire.
Measured: 0-200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJul 2015
- Primary completion13 Jul 2016
- Study completion13 Jul 2016
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Harvest
- Responsible party
- Sponsor
- Investigators
- Peter Jones, Ph.D., Principal investigator, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458027
- Sponsor's protocol ID
- B2014:115-3
- Status last verified
- Apr 2021
- First submitted
- 27 May 2015
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 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 2 - Are Acute Effects of Hemp Protein on Blood Glucose and Appetite Insulin-dependent?
- ClinicalTrials.gov ID
- NCT02458027
- Acronym / sponsor ID
- B2014:115-3
- Conditions
- Diabetes Prevention, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Harvest
- Study start
- Jul 2015
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 29 May 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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 20g Hemp Protein Shake | Experimental | Dietary Supplement: Hemp ShakeHemp protein shake, 20 grams, given once at beginning of acute trial. |
| 40 g Hemp Protein | Experimental | Dietary Supplement: HempHemp protein shake, 40 grams, given once, at beginning of acute trial. |
| 20 g Soybean Protein Shake | Active comparator | Dietary Supplement: Soybean ShakeSoybean protein shake, 20 grams, given once, at beginning of acute trial. |
| 40 g Soybean Protein | Experimental | Dietary Supplement: SoybeanSoybean protein shake, 40 grams, given once, at beginning of acute trial. |
| Control Shake | Placebo comparator | Dietary Supplement: 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.
Key exclusion criteria (4 listed)
- Restrained eaters
- Regularly skip breakfast
- Smokers
- 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 | Dietary supplement | 20g Hemp Protein Shake |
| HempHemp Protein Shake | Dietary supplement | 40 g Hemp Protein |
| Soybean ShakeSoybean Protein | Dietary supplement | 20 g Soybean Protein Shake |
| SoybeanSoybean Protein Shake | Dietary supplement | 40 g Soybean Protein |
| ControlNon-Protein Shake | Dietary supplement | Control Shake |
Primary outcome
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)
Appetite
Time frame: 0-200 minutes
Measured by VAS Questionnaire.
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.
3 secondary outcomes
Palatability of Treatments and Meal
Time frame: 5-80 minutes
Physical Comfort
Time frame: 0-200 minutes
Energy/Fatigue
Time frame: 0-200 minutes
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 23 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 Jones, Ph.D. 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, Hemp 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 4 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 23 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?
Plasma Glucose and Insulin Concentrations (time frame: 0-200 minutes). 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 23 Mar 2023.