Poor NutritionNCT03041103
Acceptability and Tolerance of a Protein and Micronutrient Fortified Food
A study testing Food Product 1 in people with Poor Nutrition, run by University of California, Davis at 1 site in United States.
Trial summary
Acceptability and tolerance of a new food product in adults and children. Read more about this study
- Who is it for?
- Ages 9 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Nutrition
- What is being tested?
- Food Product 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 30 Jun 2017
- 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 9 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- Under current medical supervision
- Non-English speaking
- Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
- Currently taking prescription drugs or supplements
- Daily use of aspirin and or non-steroidal anti-inflammatory medicines.
Show all 10Show fewer
- Indications of substance or alcohol abuse within the last 3 years
- Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
- Self-reported malabsorption
- Current enrollee in a clinical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
Acceptability and tolerance of a new food product in adults and children.
Read the detailed description
Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.
In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.
- Conditions
- Poor Nutrition
- Being tested
- Food Product 1
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Product 1Other
50 grams of fortified nutritious product from legumes
| Study group | Role | What they receive |
|---|---|---|
| Adult | Experimental | Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks Receives: Other: Food Product 1 |
| Children | Experimental | Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks Receives: Other: Food Product 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI function
GI function questionnaire with categorical numerical score
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start31 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor NutritionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single arm not blind
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl L Keen, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041103
- Sponsor's protocol ID
- 985880
- Status last verified
- Oct 2017
- First submitted
- 31 Jan 2017
- Last updated
- 6 Oct 2017
- 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 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
- ClinicalTrials.gov ID
- NCT03041103
- Acronym / sponsor ID
- 985880
- Conditions
- Poor Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Feb 2017 (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.
Acceptability and tolerance of a new food product in adults and children.
Detailed description
Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.
In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single arm not blind
| Arm | Type | Receives |
|---|---|---|
| Adult | Experimental | Other: Food Product 1Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks |
| Children | Experimental | Other: Food Product 1Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks |
Who may qualify
- Ages
- 9 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- Under current medical supervision
- Non-English speaking
- Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
- Currently taking prescription drugs or supplements
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 |
|---|---|---|
| Food Product 150 grams of fortified nutritious product from legumes | Other | Adult, Children |
Primary outcome
GI function
Time frame: at 2 weeks
GI function questionnaire with categorical numerical score
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 6 Oct 2017.
- 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.
Carl L Keen, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Product 1 in people with Poor Nutrition, run by University of California, Davis 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 0 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 6 Oct 2017. 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. 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?
GI function (time frame: at 2 weeks). 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 6 Oct 2017.