HealthyNCT02426606
Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin
A study testing Various lentil varieties (varying in slow digested starch content) 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 various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone. 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?
- Various lentil varieties (varying in slow digested starch content)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Feb 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Age 18-40 years
- BMI 20-30 kg/m2
Who cannot join
- Tobacco use
- Pregnant or breastfeeding
- Fasting blood glucose ≥ 7.0 mmol/L
- Any major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
- Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
Show all 16Show fewer
- 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 Love of Lentils (LoL) Study: The Effects of Acute Consumption of Common Lentil Varieties on Post-prandial Blood Glucose and Insulin Levels in Healthy Adult
The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.
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 500µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). White bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. Each meal will provide a total of 50g available carbohydrate. 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
- Various lentil varieties (varying in slow digested starch content)
- Keywords
- Lentils, Post-prandial, Glycemic response, Insulin response, Diabetes, Mixed meal, Glycemia, Slowly digestible starch, Post-prandial glycemia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various lentil varieties (varying in slow digested starch content)Other
Randomized, cross-over block design.
Comparison of glycemic and insulinemic responses following meals composed of:
- white rice or white rice combined with 1 of 3 different lentil varieties or
- white potato or white potato combined with 1 of 3 different lentil varieties
Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.
Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
| Study group | Role | What they receive |
|---|---|---|
| White bread | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 1 + white rice | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 2 + white rice | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 3 + white rice | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| White rice | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 1 + potato | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 2 + potato | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 3 + potato | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
| Potato | Experimental | Not described Receives: Other: Various lentil varieties (varying in slow digested starch content) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
Different meals will be consumed on separate occasions over 3-6 week period.
Measured: Acute- 2 hours following meal
Postprandial blood insulin
Different meals will be consumed on separate occasions over 3-6 week period.
Measured: Acute- 2 hours following meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Pulse Canada, Saskatchewan Pulse Growers
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
- Investigators
- Alison M Duncan, Ph.D, R.D, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426606
- Sponsor's protocol ID
- 14SE012
- Status last verified
- Oct 2016
- First submitted
- 16 Apr 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moravek D, Duncan AM, VanderSluis LB, Turkstra SJ, Rogers EJ, Wilson JM, Hawke A, Ramdath DD. Carbohydrate Replacement of Rice or Potato with Lentils Reduces the Postprandial Glycemic Response in Healthy Adults in an Acute, Randomized, Crossover Trial. J Nutr. 2018 Apr 1;148(4):535-541. doi: 10.1093/jn/nxy018.
PubMed 29659967
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Love of Lentils (LoL) Study: The Effects of Acute Consumption of Common Lentil Varieties on Post-prandial Blood Glucose and Insulin Levels in Healthy Adult
- ClinicalTrials.gov ID
- NCT02426606
- Acronym / sponsor ID
- 14SE012
- Conditions
- Healthy
- Keywords
- Lentils, Post-prandial, Glycemic response, Insulin response, Diabetes, Mixed meal, Glycemia, Slowly digestible starch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Pulse Canada, Saskatchewan Pulse Growers
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Apr 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 purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.
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 500µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). White bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. Each meal will provide a total of 50g available carbohydrate. 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| White bread | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 1 + white rice | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 2 + white rice | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 3 + white rice | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| White rice | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 1 + potato | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 2 + potato | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Lentil 3 + potato | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
| Potato | Experimental | Other: Various lentil varieties (varying in slow digested starch content) |
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
- BMI 20-30 kg/m2
Key exclusion criteria (16 listed)
- Tobacco use
- Pregnant or breastfeeding
- Fasting blood glucose ≥ 7.0 mmol/L
- Any major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
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 |
|---|---|---|
| Various lentil varieties (varying in slow digested starch content)Randomized, cross-over block design. Comparison of glycemic and insulinemic responses following meals composed of: * white rice or white rice combined with 1 of 3 different lentil varieties or * white potato or white potato combined with 1 of 3 different lentil varieties Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC. Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit). | Other | Lentil 1 + potato, Lentil 1 + white rice, Lentil 2 + potato, Lentil 2 + white rice, Lentil 3 + potato, Lentil 3 + white rice, Potato, White bread, White rice |
Primary outcome
Postprandial blood glucose
Time frame: Acute- 2 hours following meal
Different meals will be consumed on separate occasions over 3-6 week period.
Postprandial blood insulin
Time frame: Acute- 2 hours following meal
Different meals will be consumed on separate occasions over 3-6 week period.
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 25 Oct 2016.
- Derived from this study: PubMed 29659967Moravek D, Duncan AM, VanderSluis LB, Turkstra SJ, Rogers EJ, Wilson JM, Hawke A, Ramdath DD. Carbohydrate Replacement of Rice or Potato with Lentils Reduces the Postprandial Glycemic Response in Healthy Adults in an Acute, Randomized, Crossover Trial. J Nutr. 2018 Apr 1;148(4):535-541. doi: 10.1093/jn/nxy018.
- 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.
Alison M Duncan, Ph.D, R.D principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Various lentil varieties (varying in slow digested starch content) 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 16 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 25 Oct 2016. 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: Acute- 2 hours following meal). 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?
On the ClinicalTrials.gov record for NCT02426606, which also lists 1 linked publication.
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 25 Oct 2016.