Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03041103

Enrollment

Registered

2017-02-02

Start date

2017-01-31

Completion date

2017-06-30

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Nutrition

Brief summary

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.

Interventions

OTHERFood Product 1

50 grams of fortified nutritious product from legumes

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Single arm not blind

Eligibility

Sex/Gender

ALL

Age

9 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

° 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.

Design outcomes

Primary

Measure	Time frame	Description
GI function	at 2 weeks	GI function questionnaire with categorical numerical score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026