Healthy AdultsNCT03779971
Energy Value of Lentils and Chickpeas
A study testing Lentil Containing Diet and Chickpea Containing Diet in people with Healthy Adults, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
This study is being conducted to determine the digestibility of and available energy from pulses. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Lentil Containing Diet and Chickpea Containing Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 23 Mar 2020
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 19 and 38 kg/m2
- Age 25 to 75 years during intervention
Who cannot join
- Known (self-reported) allergy or adverse reaction to study foods
- Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
- History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
- History of certain cancer diagnosis or treatment in the last 3 years
- Smoking or use of tobacco products in the past 6 months
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
Show all 10Show fewer
- Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
This study is being conducted to determine the digestibility of and available energy from pulses.
Read the detailed description
Previous studies have demonstrated that the metabolizable energy (energy available to the body) from tree nuts is less than predicted by the Atwater factors (the standard approach to determining calorie value of a food). The Atwater approach is over 100 years old and is inaccurate for some foods. This study will be conducted to determine the metabolizable energy from two pulses, lentils and chickpeas. The study will be a human nutrition intervention involving consumption of a controlled diet followed by collection of urine and feces.
- Conditions
- Healthy Adults
- Being tested
- Control Diet, Lentil Containing Diet, Chickpea Containing Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control DietOther
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.
Lentil Containing DietOther
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.
Chickpea Containing DietOther
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses. Receives: Other: Control Diet |
| Lentil | Experimental | The lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils. Receives: Other: Lentil Containing Diet |
| Chickpeas | Experimental | The chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas. Receives: Other: Chickpea Containing Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy excreted in feces and urine
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
Measured: Cumulative from day 10-17
Energy excreted in feces and urine
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
Measured: Cumulative from day 39-46
Energy excreted in feces and urine
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
Measured: Cumulative from day 57-64
Secondary outcomes (2)
Nitrogen excreted in feces and urine
Nitrogen (g) excreted in feces and urine will be measured.
Measured: Cumulative from day 10-17, day 39-46, day 57-64
Fat excreted in feces
Fat (g) excreted in feces will be measured.
Measured: Cumulative from day 10-17, day 39-46, day 57-64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start6 Nov 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
- Investigators
- Roman Mirecki, MS, Study director, US Department of Agriculture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779971
- Sponsor's protocol ID
- HS66-Lentil/Chickpea Study
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2018
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Value of Lentils and Chickpeas
- ClinicalTrials.gov ID
- NCT03779971
- Acronym / sponsor ID
- HS66-Lentil/Chickpea Study
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 19 Dec 2018 (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.
This study is being conducted to determine the digestibility of and available energy from pulses.
Detailed description
Previous studies have demonstrated that the metabolizable energy (energy available to the body) from tree nuts is less than predicted by the Atwater factors (the standard approach to determining calorie value of a food). The Atwater approach is over 100 years old and is inaccurate for some foods. This study will be conducted to determine the metabolizable energy from two pulses, lentils and chickpeas. The study will be a human nutrition intervention involving consumption of a controlled diet followed by collection of urine and feces.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control DietThe placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses. |
| Lentil | Experimental | Other: Lentil Containing DietThe lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils. |
| Chickpeas | Experimental | Other: Chickpea Containing DietThe chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 19 and 38 kg/m2
- Age 25 to 75 years during intervention
Key exclusion criteria (10 listed)
- Known (self-reported) allergy or adverse reaction to study foods
- Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
- History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
- History of certain cancer diagnosis or treatment in the last 3 years
- Smoking or use of tobacco products in the past 6 months
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 |
|---|---|---|
| Control DietParticipants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans. | Other | Control |
| Lentil Containing DietParticipants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils. | Other | Lentil |
| Chickpea Containing DietParticipants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas. | Other | Chickpeas |
Primary outcome
Energy excreted in feces and urine
Time frame: Cumulative from day 10-17
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
Energy excreted in feces and urine
Time frame: Cumulative from day 39-46
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
Energy excreted in feces and urine
Time frame: Cumulative from day 57-64
Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
2 secondary outcomes
Nitrogen excreted in feces and urine
Time frame: Cumulative from day 10-17, day 39-46, day 57-64
Fat excreted in feces
Time frame: Cumulative from day 10-17, day 39-46, day 57-64
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 11 May 2020.
- 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.
Roman Mirecki, MS study director
US Department of Agriculture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lentil Containing Diet and Chickpea Containing Diet in people with Healthy Adults, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
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 10 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 11 May 2020. 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 United States. 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?
Energy excreted in feces and urine (time frame: Cumulative from day 10-17). The study lists 3 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 11 May 2020.