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Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

Primary Purpose

Poor Nutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Product 1
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Poor Nutrition

Eligibility Criteria

9 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

° 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.

Sites / Locations

  • Department of Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adult

Children

Arm Description

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

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

Outcomes

Primary Outcome Measures

GI function
GI function questionnaire with categorical numerical score

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
October 3, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03041103
Brief Title
Acceptability and Tolerance of a Protein and Micronutrient Fortified Food
Official Title
Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Nutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm not blind
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult
Arm Type
Experimental
Arm Description
Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks
Arm Title
Children
Arm Type
Experimental
Arm Description
Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks
Intervention Type
Other
Intervention Name(s)
Food Product 1
Intervention Description
50 grams of fortified nutritious product from legumes
Primary Outcome Measure Information:
Title
GI function
Description
GI function questionnaire with categorical numerical score
Time Frame
at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl L Keen, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

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