HealthyNCT02940158
Various Serving Sizes of Lentils on Blood Glucose and Insulin
A study testing 1/4 cup- Small red lentil, 1/4 cup- Small green lentil and 1/4 cup- corn in people with Healthy, run by University of Guelph at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1/4 cup- Small red lentil, 1/4 cup- Small green lentil and 1/4 cup- corn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 8 Jan 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Age 18-40 years
- Body mass index (BMI) 20-30 kg/m2
Who cannot join
- Tobacco use
- Pregnant or breastfeeding
- Fasting blood glucose ≥ 7.0 mmol/L
- Two hour blood glucose ≥ 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage)
- Any major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
Show all 17Show fewer
- Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
- Blood pressure >140/90 mm Hg
- Natural health products (NHPs) used for glycemic control
- Probiotic supplements
- Dietary fibre supplements
- Consumption of >4 servings of pulses per week
- Food allergy or non-food life threatening allergy
- Shift workers
- Alcohol consumption >14 drinks/week or >4 drinks/sitting
- Recent or intended significant weight loss or gain (>4 kg in previous 3 months)
- Elite athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Various Serving Sizes of Lentils and Other Starchy Meals on Post Prandial Blood Glucose Response and Insulin
The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).
Read the detailed description
Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: two types of lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.
- Conditions
- Healthy
- Being tested
- 1/4 cup- Small red lentil, 1/4 cup- Small green lentil, 1/4 cup- corn, 1/4 cup- macaroni, 1/4 cup- white potato
- Keywords
- lentils, diabetes, glycemia, insulin, glucose
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1/4 cup- Small red lentilOther
1/4 cup- Small green lentilOther
1/4 cup- cornOther
1/4 cup- macaroniOther
1/4 cup- white potatoOther
1/4 cup- white riceOther
1/2 cup- small red lentilOther
1/2 cup- small green lentilOther
1/2 cup- cornOther
1/2 cup- macaroniOther
1/2 cup- white potatoOther
1/2 cup- white riceOther
| Study group | Role | What they receive |
|---|---|---|
| 1/2 cup | Other | 1/2 cup serving size arm Receives: Other: 1/2 cup- small red lentil; Other: 1/2 cup- small green lentil; Other: 1/2 cup- corn; Other: 1/2 cup- macaroni; Other: 1/2 cup- white potato; Other: 1/2 cup- white rice |
| 1/4 cup | Other | 1/4 cup serving size arm Receives: Other: 1/4 cup- Small red lentil; Other: 1/4 cup- Small green lentil; Other: 1/4 cup- corn; Other: 1/4 cup- macaroni; Other: 1/4 cup- white potato; Other: 1/4 cup- white rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Blood Glucose
Measured: 2 hours Postprandial
Postprandial Blood Insulin
Measured: 2 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940158
- Sponsor's protocol ID
- 16AU001
- Status last verified
- May 2018
- First submitted
- 25 Sep 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Various Serving Sizes of Lentils and Other Starchy Meals on Post Prandial Blood Glucose Response and Insulin
- ClinicalTrials.gov ID
- NCT02940158
- Acronym / sponsor ID
- 16AU001
- Conditions
- Healthy
- Keywords
- lentils, diabetes, glycemia, insulin, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers
- Study start
- Oct 2016
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 20 Oct 2016 (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 purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).
Detailed description
Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: two types of lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/2 cup | Other | Other: 1/2 cup- small red lentil, Other: 1/2 cup- small green lentil, Other: 1/2 cup- corn, Other: 1/2 cup- macaroni, Other: 1/2 cup- white potato, Other: 1/2 cup- white rice1/2 cup serving size arm |
| 1/4 cup | Other | Other: 1/4 cup- Small red lentil, Other: 1/4 cup- Small green lentil, Other: 1/4 cup- corn, Other: 1/4 cup- macaroni, Other: 1/4 cup- white potato, Other: 1/4 cup- white rice1/4 cup serving size arm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Age 18-40 years
- Body mass index (BMI) 20-30 kg/m2
Key exclusion criteria (17 listed)
- Tobacco use
- Pregnant or breastfeeding
- Fasting blood glucose ≥ 7.0 mmol/L
- Two hour blood glucose ≥ 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage)
- Any major medical condition including a history of AIDS or hepatitis
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 |
|---|---|---|
| 1/4 cup- Small red lentil | Other | 1/4 cup |
| 1/4 cup- Small green lentil | Other | 1/4 cup |
| 1/4 cup- corn | Other | 1/4 cup |
| 1/4 cup- macaroni | Other | 1/4 cup |
| 1/4 cup- white potato | Other | 1/4 cup |
| 1/4 cup- white rice | Other | 1/4 cup |
| 1/2 cup- small red lentil | Other | 1/2 cup |
| 1/2 cup- small green lentil | Other | 1/2 cup |
| 1/2 cup- corn | Other | 1/2 cup |
| 1/2 cup- macaroni | Other | 1/2 cup |
| 1/2 cup- white potato | Other | 1/2 cup |
| 1/2 cup- white rice | Other | 1/2 cup |
Primary outcome
Postprandial Blood Glucose
Time frame: 2 hours Postprandial
Postprandial Blood Insulin
Time frame: 2 hours postprandial
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 8 May 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1/4 cup- Small red lentil, 1/4 cup- Small green lentil and 1/4 cup- corn in people with Healthy, run by University of Guelph 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 3 inclusion and 17 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 8 May 2018. 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. 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?
Postprandial Blood Glucose (time frame: 2 hours Postprandial). The study lists 2 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 8 May 2018.