Impact of a Nutritional Supplement on Metabolic Health

NCT02239198 | Completed

• 2 other identifiers: Nutrition Bar TrialsCHORIbar
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Prevention

Keywords

HDL; nutrition bar

Outcome Measures

Primary Outcomes (1)

• High density lipoprotein

  1 year

Study Arms (3)

C

EXPERIMENTAL

Nutrition bar without omega-3 fatty acids

Other: Nutrition bar

B

EXPERIMENTAL

Nutrition bar without added minerals and vitamins

Other: Nutrition bar

A

ACTIVE COMPARATOR

Complete nutrition bar

Other: Nutrition bar

Interventions

Nutrition bar OTHER

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.

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

Related Publications (2)

• Mietus-Snyder ML, Shigenaga MK, Suh JH, Shenvi SV, Lal A, McHugh T, Olson D, Lilienstein J, Krauss RM, Gildengoren G, McCann JC, Ames BN. A nutrient-dense, high-fiber, fruit-based supplement bar increases HDL cholesterol, particularly large HDL, lowers homocysteine, and raises glutathione in a 2-wk trial. FASEB J. 2012 Aug;26(8):3515-27. doi: 10.1096/fj.11-201558. Epub 2012 May 1.

  PMID: 22549511 BACKGROUND

• Mietus-Snyder M, Narayanan N, Krauss RM, Laine-Graves K, McCann JC, Shigenaga MK, McHugh TH, Ames BN, Suh JH. Randomized nutrient bar supplementation improves exercise-associated changes in plasma metabolome in adolescents and adult family members at cardiometabolic risk. PLoS One. 2020 Oct 20;15(10):e0240437. doi: 10.1371/journal.pone.0240437. eCollection 2020.

  PMID: 33079935 DERIVED

Study Officials

• Bruce Ames

  Children's Hospital & Research Center at Oakland

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: April 5, 2016
• Primary Completion: April 5, 2017
• Study Completion: April 13, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)