Assessment of a New Food Product in Metabolically at Risk Children
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 9 - 13 |
| Updated: | 3/23/2019 |
| Start Date: | June 15, 2017 |
| End Date: | January 29, 2028 |
| Contact: | Carl L Keen, PhD |
| Email: | clkeen@ucdavis.edu |
| Phone: | 530-752-6331 |
Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
The current study conducted will lend toward the optimization of the development of a food
product that will promote a shift towards improved metabolic health. Specifically, this trial
will determine the optimal level of protein needed to elicit positive changes in markers of
inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular
function, and the relationship of these changes to the metabolome in school aged children (9
- 13 years of age).
product that will promote a shift towards improved metabolic health. Specifically, this trial
will determine the optimal level of protein needed to elicit positive changes in markers of
inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular
function, and the relationship of these changes to the metabolome in school aged children (9
- 13 years of age).
Each participant will be asked to participate in a screening and 2 study intervention visits.
Each intervention visit will include anthropometric measures, complete the education
component, vascular function tests, and a blood draw and spot urine. The screening visit will
confirm the child's eligibility for study enrollment and will serve to acclimate the child to
the vascular function, and physical activity measurements. The remaining 2 visits will be
scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical
activity monitor, which in addition to tracking physical activity, will also be used to
incorporate a nutrition education program. The parent/guardian will be asked to help with
providing the child the daily food product and to help their child fill out the compliance
log. Volunteers will also be sought for stool and saliva collection.
Each intervention visit will include anthropometric measures, complete the education
component, vascular function tests, and a blood draw and spot urine. The screening visit will
confirm the child's eligibility for study enrollment and will serve to acclimate the child to
the vascular function, and physical activity measurements. The remaining 2 visits will be
scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical
activity monitor, which in addition to tracking physical activity, will also be used to
incorporate a nutrition education program. The parent/guardian will be asked to help with
providing the child the daily food product and to help their child fill out the compliance
log. Volunteers will also be sought for stool and saliva collection.
Inclusion Criteria:
- 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
- Access to a smart phone or tablet at least 1x / week; and willing to download a free
applications associated with the study
Exclusion Criteria:
- Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- Under current medical supervision
- Tanner Score = 4
- Non-English speaking
- Current participation in a daily exercise routine of moderate or high intensity
- Self-reported presence of disease, a history of serious illness, or who are currently
under acute medical care.
- Currently taking prescription drugs or supplements
- Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish
oil, and oil supplements.
- Self-reported malabsorption or gastrointestinal issues
- Current enrollee in a clinical research study.
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