Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

Poor Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041103
• Other study ID #: 985880
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: October 3, 2017
• Start date: January 31, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acceptability and tolerance of a new food product in adults and children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 60 Years

Eligibility

° 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.

Related Conditions & MeSH terms

• Malnutrition
• Poor Nutrition

Intervention

Other:
• Food Product 1
50 grams of fortified nutritious product from legumes

Locations

Country	Name	City	State
United States	Department of Nutrition	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI function	GI function questionnaire with categorical numerical score	at 2 weeks