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
About this trial
This is an interventional other trial for Poor Nutrition
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.
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
NCT ID
NCT03041103
First Posted
January 31, 2017
Last Updated
October 3, 2017
Sponsor
University of California, Davis
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
Learn more about this trial
Acceptability and Tolerance of a Protein and Micronutrient Fortified Food
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