Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

Study Overview
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Brief Summary
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Acceptability and tolerance of a new food product in adults and children.

Detailed Description
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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.

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

Conditions
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Poor Nutrition

Intervention / Treatment
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* Other: Food Product 1


Participation Criteria
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Eligibility Criteria
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° 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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm not blind
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult<br>Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks | Other: Food Product 1<br>* 50 grams of fortified nutritious product from legumes<br>|
| Experimental: Children<br>Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks | Other: Food Product 1<br>* 50 grams of fortified nutritious product from legumes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI function | GI function questionnaire with categorical numerical score | at 2 weeks |