Impact of a Nutritional Supplement on Metabolic Health
Completed · Not applicable
Conditions studied: Cardiovascular Disease Prevention
In brief
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, measurable dietary improvements and weight stabilization, yet falls short of restoring optimal nutritional status and metabolism. A carefully formulated nutritional supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct micronutrient deficiencies in overweight or obese adults and children. This may have a beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome, gut inflammation, redox status, immune function and DNA integrity, and may favorably influence weight change and fat distribution. The investigators believe that the improvements seen with CHORIBAR trials will be mediated at the level of generalized enhancement in cellular metabolism that are not readily achieved with lifestyle counseling alone. The investigators suspect this is due to many nutritional barriers, some of which are disproportionately borne by inner city populations, such as cost and access to healthy food. The investigators hypothesize that a nutritional supplement like the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic and weight outcomes.
Key facts
- Study ID
- NCT02239198
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 16
- Starts
- 2016-04-05
- Expected to finish
- 2017-04-13
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Children's Hospital & Research Center Oakland — Oakland, California, United States
Full record on ClinicalTrials.gov
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