Cardiovascular Disease Prevention Clinical Trial
Official title:
Attenuating the Micronutrient Malnutrition of Overnutrition (AMMO)
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.
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-cholesterol (HDL-c), particularly large-HDL (HDL-L) in most lean but only in some overweight/obese individuals. Obesity is associated with poor gastrointestinal health and systemic inflammation, which are also associated with low HDL. Our hypothesis is that a carefully formulated nutritional supplement bar delivered in a whole food matrix can correct micronutrient deficiencies in obese adults and have a beneficial impact on indices of insulin dysregulation and the metabolic syndrome. The aims of this project are 1) to characterize the effect size on indices of lipid profile, homocysteine, inflammation, insulin resistance, micronutrient levels, DNA integrity, hunger and satiety, BMI, waist circumference, and blood pressure with different formulations of CHORI bar taken twice daily for periods ranging from 2-8 weeks. We will also evaluate gut inflammation, redox status, tissue metals, and DNA integrity with novel exploratory assays that may serve as markers for micronutrient malnutrition and chronic disease risk. 2) Where significant improvement in the outcome variables is observed, we will attempt to "deconstruct" the bars and attempt to determine the active ingredients responsible for these changes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06142838 -
Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators
|
N/A |