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Impact of a Nutritional Supplement on Metabolic Health (CHORIBar)

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ClinicalTrials.gov Identifier: NCT02239198
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
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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, 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Prevention Other: Nutrition bar Not Applicable

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-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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Attenuating the Micronutrient Malnutrition of Overnutrition (AMMO)
Actual Study Start Date : April 5, 2016
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 13, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: C
Nutrition bar without omega-3 fatty acids
 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.
Experimental: B
Nutrition bar without added minerals and vitamins
 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.
Active Comparator: A
Complete nutrition bar
 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.


Outcome Measures
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Primary Outcome Measures :
  1. High density lipoprotein [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239198


Locations
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United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Bruce Ames Children's Hospital & Research Center at Oakland
Study Director: Ashutosh Lal, MD Children's Hospital & Research Center at Oakland
Study Director: Joyce McCann, PhD Children's Hospital & Research Center at Oakland
Study Director: Michele Mietus-Snyder, MD Children's Hospital & Research Center at Oakland
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT02239198    
Other Study ID Numbers: Nutrition Bar Trials
CHORIbar ( Other Grant/Funding Number: Ames Foundation )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by UCSF Benioff Children's Hospital Oakland:
HDL
nutrition bar
Additional relevant MeSH terms:
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Cardiovascular Diseases