AppetiteNCT03128684
The Effects of Lentil-containing Food Products on Satiety and Food Intake
A study testing Small Green Lentil Muffin, Split Red Lentil Muffin and Wheat Muffin in people with Appetite and Satiety, run by University of Guelph at 1 site in Canada.
Trial summary
The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite, Satiety, Food Intake
- What is being tested?
- Small Green Lentil Muffin, Split Red Lentil Muffin and Wheat Muffin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 9 Feb 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 males and females
- Age 18 to 40 years old
- BMI 20-30 kg/m2
Who cannot join
- Blood pressure greater than 140/90 mmHg
- Major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
- Any medication use except stable dose (3 months) of oral contraceptives, blood pressure or statin medications
- Tobacco use
- Probiotic supplement use
Show all 18Show fewer
- Dietary fibre supplement use
- Natural health products (NHPs) used for glycemic control (all other NHPs are ok, as long as stable for 3 months)
- Pulse consumption greater than 4 servings per week
- Food allergy or non-food life threatening allergy
- Pregnant or breastfeeding
- Alcohol consumption of greater than 14 drinks per week or greater than 4 drinks per sitting
- Recent or intended significant weight loss or gain (greater than 4kg in previous 3 months)
- Elite athletes
- Shift workers
- Breakfast skippers
- Score greater than 11, 9, or 8 on the Three Factor Eating Questionnaire (TFEQ) Cognitive Restraint, Disinhibition, and Hunger scales, respectively
- Dislike of frozen pizza
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Lentil-containing Food Products on Satiety and Food Intake in Healthy Adults
The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults.
Read the detailed description
The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils (small green Eston and red split) within food products (muffins and chilies) on satiety and food intake in healthy adults, for a total of 6 study treatments. A total of 3 to 6 study visits (corresponding to consuming all muffins and/or all chilies) will take place where participants will consume one of the study treatments and subsequently complete satiety questionnaires over 180 minutes to measure satiety as subjective appetite sensations (hunger, fullness, desire to eat, and prospective food consumption). At 180 minutes, participants will receive ad libitum pizza and bottled water to consume until they are comfortably full for a measure of weighed food intake. At the end of each study visit, participants will be given a food scale and instructed to weigh and record all food and drink consumed for the remainder of the day for a measure of 24-hour energy intake.
- Conditions
- Appetite, Satiety, Food Intake
- Being tested
- Small Green Lentil Muffin, Split Red Lentil Muffin, Wheat Muffin, Small Green Lentil Chili, Split Red Lentil Chili
- Keywords
- lentils, satiety, appetite, food intake, 24-hour energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Green Lentil MuffinOther
Consumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
Split Red Lentil MuffinOther
Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
Wheat MuffinOther
Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes
Small Green Lentil ChiliOther
Consumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes
Split Red Lentil ChiliOther
Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes
Rice ChiliOther
Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes
| Study group | Role | What they receive |
|---|---|---|
| Small Green Lentil Muffin | Experimental | Not described Receives: Other: Small Green Lentil Muffin |
| Split Red Lentil Muffin | Experimental | Not described Receives: Other: Split Red Lentil Muffin |
| Wheat Muffin | Placebo comparator | Not described Receives: Other: Wheat Muffin |
| Small Green Lentil Chili | Experimental | Not described Receives: Other: Small Green Lentil Chili |
| Split Red Lentil Chili | Experimental | Not described Receives: Other: Split Red Lentil Chili |
| Rice Chili | Placebo comparator | Not described Receives: Other: Rice Chili |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
Satiety will be measured using 100mm visual analog scales (VAS) rating appetite sensations of hunger, fullness, desire to eat, and prospective consumption
Measured: Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption
Food Intake
Food intake will be measured as kilocalories using an ad libitum cheese pizza test meal
Measured: Acute: 180 minutes following consumption of treatment
Secondary outcomes (1)
24-hour Energy Intake
24-hour energy intake will be measured by providing electronic food scales to participants to weigh and record all food and drink consumed for the rest of the day after leaving the study visit
Measured: Acute: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 May 2017
- Primary completion8 Feb 2018
- Study completion9 Feb 2018
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 AppetiteStudies 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
- 24 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, Pulse Canada
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128684
- Sponsor's protocol ID
- REB16-12-883
- Status last verified
- Dec 2018
- First submitted
- 20 Apr 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark SL, Ramdath DD, King BV, O'Connor KE, Aliani M, Hawke A, Duncan AM. Food Type and Lentil Variety Affect Satiety Responses but Not Food Intake in Healthy Adults When Lentils Are Substituted for Commonly Consumed Carbohydrates. J Nutr. 2019 Jul 1;149(7):1180-1188. doi: 10.1093/jn/nxz050.
PubMed 31152672
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lentil-containing Food Products on Satiety and Food Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT03128684
- Acronym / sponsor ID
- REB16-12-883
- Conditions
- Appetite, Satiety, Food Intake
- Keywords
- lentils, satiety, appetite, food intake, 24-hour energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers, Pulse Canada
- Study start
- 1 May 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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 Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults.
Detailed description
The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils (small green Eston and red split) within food products (muffins and chilies) on satiety and food intake in healthy adults, for a total of 6 study treatments. A total of 3 to 6 study visits (corresponding to consuming all muffins and/or all chilies) will take place where participants will consume one of the study treatments and subsequently complete satiety questionnaires over 180 minutes to measure satiety as subjective appetite sensations (hunger, fullness, desire to eat, and prospective food consumption). At 180 minutes, participants will receive ad libitum pizza and bottled water to consume until they are comfortably full for a measure of weighed food intake. At the end of each study visit, participants will be given a food scale and instructed to weigh and record all food and drink consumed for the remainder of the day for a measure of 24-hour energy intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Small Green Lentil Muffin | Experimental | Other: Small Green Lentil Muffin |
| Split Red Lentil Muffin | Experimental | Other: Split Red Lentil Muffin |
| Wheat Muffin | Placebo comparator | Other: Wheat Muffin |
| Small Green Lentil Chili | Experimental | Other: Small Green Lentil Chili |
| Split Red Lentil Chili | Experimental | Other: Split Red Lentil Chili |
| Rice Chili | Placebo comparator | Other: Rice Chili |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females
- Age 18 to 40 years old
- BMI 20-30 kg/m2
Key exclusion criteria (18 listed)
- Blood pressure greater than 140/90 mmHg
- Major medical condition including a history of AIDS or hepatitis
- Medical or surgical event requiring hospitalization within 3 months of randomization
- Any medication use except stable dose (3 months) of oral contraceptives, blood pressure or statin medications
- Tobacco use
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 |
|---|---|---|
| Small Green Lentil MuffinConsumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes | Other | Small Green Lentil Muffin |
| Split Red Lentil MuffinConsumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes | Other | Split Red Lentil Muffin |
| Wheat MuffinConsumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes | Other | Wheat Muffin |
| Small Green Lentil ChiliConsumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes | Other | Small Green Lentil Chili |
| Split Red Lentil ChiliConsumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes | Other | Split Red Lentil Chili |
| Rice ChiliConsumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes | Other | Rice Chili |
Primary outcome
Satiety
Time frame: Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption
Satiety will be measured using 100mm visual analog scales (VAS) rating appetite sensations of hunger, fullness, desire to eat, and prospective consumption
Food Intake
Time frame: Acute: 180 minutes following consumption of treatment
Food intake will be measured as kilocalories using an ad libitum cheese pizza test meal
1 secondary outcome
24-hour Energy Intake
Time frame: Acute: 24 hours
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 19 Dec 2018.
- Derived from this study: PubMed 31152672Clark SL, Ramdath DD, King BV, O'Connor KE, Aliani M, Hawke A, Duncan AM. Food Type and Lentil Variety Affect Satiety Responses but Not Food Intake in Healthy Adults When Lentils Are Substituted for Commonly Consumed Carbohydrates. J Nutr. 2019 Jul 1;149(7):1180-1188. doi: 10.1093/jn/nxz050.
- 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 Small Green Lentil Muffin, Split Red Lentil Muffin and Wheat Muffin in people with Appetite and Satiety, 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 18 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 19 Dec 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. 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?
Satiety (time frame: Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption). 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 NCT03128684, 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 19 Dec 2018.