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Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

NCT ID: NCT03041103

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

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.

Conditions

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Poor Nutrition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Single arm not blind
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adult

Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks

Group Type EXPERIMENTAL

Food Product 1

Intervention Type OTHER

50 grams of fortified nutritious product from legumes

Children

Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks

Group Type EXPERIMENTAL

Food Product 1

Intervention Type OTHER

50 grams of fortified nutritious product from legumes

Interventions

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Food Product 1

50 grams of fortified nutritious product from legumes

Intervention Type OTHER

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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Department of Nutrition

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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985880

Identifier Type: -

Identifier Source: org_study_id