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Impact of a Nutritional Supplement on Metabolic Health

NCT02239198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-04-18

No results posted yet for this study

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, 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.

Conditions

  • Cardiovascular Disease Prevention

Interventions

OTHER

Nutrition bar

The nutrition bar has been formulated to help achieve balanced nutrition with a polyphenolic-rich whole food matrix with vitamins, minerals, omega-3 fatty acids, and fiber at generally physiologic doses intended not to replace but to supplement a typical diet.

Sponsors & Collaborators

  • USDA Beltsville Human Nutrition Research Center

    collaborator FED

  • UCSF Benioff Children's Hospital Oakland

    lead OTHER

Principal Investigators

  • Bruce Ames · Children's Hospital & Research Center at Oakland

  • Ashutosh Lal, MD · Children's Hospital & Research Center at Oakland

  • Joyce McCann, PhD · Children's Hospital & Research Center at Oakland

  • Michele Mietus-Snyder, MD · Children's Hospital & Research Center at Oakland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-05
Primary Completion
2017-04-05
Completion
2017-04-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239198 on ClinicalTrials.gov