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Trial record 8 of 50470 for:    will | Recruiting, Not yet recruiting, Available Studies

Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults

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ClinicalTrials.gov Identifier: NCT03989882
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University

Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Fecal bacteria population [ Time Frame: Change from baseline fecal bacteria at 30 days ]
    analyzed by 16sRNA sequencing
  • Fecal immunoglobulin A [ Time Frame: Change from baseline fecal immunoglobulin A at 30 days ]
    analyzed by enzyme-linked immunoassay
  • Fecal zonulin [ Time Frame: Change from baseline fecal zonulin at 30 days ]
    analyzed by enzyme-linked immunoassay
  • Fecal short chain fatty acids [ Time Frame: Change from baseline fecal shortchain fatty acids at 30 days ]
    analyzed by gas chromatography
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Blood glucose [ Time Frame: Change from baselineblood glucose at 30 days ]
    analyzed using clinical chemistry analyzer
  • blood glycated hemoglobin [ Time Frame: Change from baseline blood glycated hemoglobin at 30 days ]
    analyzed using clinical chemistry analyzer
  • blood high sensitivity C-reactive protein [ Time Frame: Change from baseline blood high sensitivity C-reactive protein at 30 days ]
    analyzed using clinical chemistry analyzer
  • blood insulin level [ Time Frame: Change from baselineblood insulin level at 30 days ]
    analyzed by enzyme-linked immunoassay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Official Title  ICMJE Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Brief Summary The objective of this pilot study is to determine the effects of wheat germ (WG) supplementation on gut health and subsequent effects on markers of inflammation and insulin resistance in overweight individuals. WG is a by-product of wheat processing and an excellent source of omega-3 fatty acids, vitamin E, and fiber. A few studies have shown the health benefits of WG including gut modulatory potential, but the prebiotic functions of WG in humans remain in question and warrant further investigation.
Detailed Description Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) between 18 to 45 years old regardless of gender will be recruited. They will be randomly assigned to receive two energy balls containing 30 grams of wheat germ or corn meal (control) in a 4-wk randomized controlled pilot trial. The energy balls will contain wheat germ or corn meal, peanut butter, honey and milk. Participants will be asked to consume two energy balls daily for 4 weeks. Anthropometric measures, questionnaires (medical, diet, physical activity and bowel habits), blood and fecal samples will be collected at baseline and at the end of the four week study. The investigator's primary outcome variables will be changes in fecal bacteria, immunoglobulin A, zonulin and short chain fatty acids while secondary outcome variables will be alterations in plasma markers of inflammation and insulin resistance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants will not know their treatment assignment and energy balls will be in an opaque container.
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Insulin Resistance
  • Inflammation
Intervention  ICMJE
  • Other: Wheat germ energy ball
    wheat germ mixed other ingredients to make an energy ball
  • Other: Control
    corresponding control without wheat germ
Study Arms  ICMJE
  • Experimental: Wheat germ
    Wheat germ energy balls containing 30 g of wheat germ, peanut butter, and honey to form 2 energy balls that is approximately 200 kcal. Two energy balls will be consumed daily for 30 days.
    Intervention: Other: Wheat germ energy ball
  • Placebo Comparator: Control
    Control energy ball containing 30 g of cornmeal, peanut butter, and honey to form 2 energy balls that is approximately 200 kcal. Two energy balls will be consumed daily for 30 days.
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old

Exclusion Criteria:

diagnosed diabetes, heart disease, and cancer tobacco use excessive alcohol use taking mega-doses of antioxidant/vitamin supplements or medications that could interfere with study endpoints such as antibiotics, anti-inflammatory, and glucose-lowering medications major surgery occurring within 6 months pregnant or lactating previous high intake of wheat germ or sensitivity to gluten and wheat products.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Edralin Lucas, PhD (405)744-3132 edralin.a.lucas@okstate.edu
Contact: Sam Emerson, PhD (405)744-2303 sam.emerson@okstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989882
Other Study ID Numbers  ICMJE HS1888
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oklahoma State University
Study Sponsor  ICMJE Oklahoma State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edralin Lucas, PhD Okklahoma State University
PRS Account Oklahoma State University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP