Acceptability and Tolerance of a Protein and Micronutrient Fortified Food



Status:Completed
Conditions:Food Studies
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:9 - 60
Updated:10/8/2017
Start Date:January 31, 2017
End Date:June 30, 2017

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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.

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.

° Inclusion Criteria:

- Male, 40-60 years old

- Male or Female 9-13 years old

- Subject is willing and able to comply with the study protocols

- Subject is willing to consume the test products

Exclusion Criteria:

- 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.

- 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.
We found this trial at
1
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Davis, California 95616
Phone: 530-752-4950
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Davis, CA
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