Status:
COMPLETED
Impact of a Nutritional Supplement on Metabolic Health
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
USDA Beltsville Human Nutrition Research Center
Conditions:
Cardiovascular Disease Prevention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There are prevalent micronutrient and fiber deficiencies in a significant proportion of US population, particularly among the overweight or obese. Intensive lifestyle counseling results in modest, mea...
Detailed Description
With our USDA partners, we have developed a whole-food, multi-component nutrient bars. Previous pilot studies demonstrated that short-term bar consumption results in favorable increases in HDL-cholest...
Eligibility Criteria
Inclusion
- Either taking no dietary supplements or willing to discontinue any dietary supplements for two weeks preceding the trial.
- Age \>18 years
- BMI \<40
- Blood pressure \<140/90 mmHg, or stable blood pressure on medicines for past 3 months
Exclusion
- Known diabetes mellitus according to the 2010 ADA criteria, but pre-diabetic subjects with known impaired glucose tolerance (fasting glucose 101-125, and 2-hour post-prandial glucose level 141-200 mg/dL) can remain eligible.
- Weight loss pharmacotherapy.
- Lipid-lowering medication as this will alter the lipid profile being measured.
- Renal disease as this may affect blood pressure and dietary requirements.
- Smoking
- Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
Key Trial Info
Start Date :
April 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02239198
Start Date
April 5 2016
End Date
April 13 2017
Last Update
April 18 2017
Active Locations (1)
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1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609