Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Overweight Insulin Resistance Inflammation Other: Wheat germ energy ball Other: Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
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.
Other: Wheat germ energy ball
wheat germ mixed other ingredients to make an 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.
Other: Control
corresponding control without wheat germ




Primary Outcome Measures :
  1. Fecal bacteria population [ Time Frame: Change from baseline fecal bacteria at 30 days ]
    analyzed by 16sRNA sequencing

  2. Fecal immunoglobulin A [ Time Frame: Change from baseline fecal immunoglobulin A at 30 days ]
    analyzed by enzyme-linked immunoassay

  3. Fecal zonulin [ Time Frame: Change from baseline fecal zonulin at 30 days ]
    analyzed by enzyme-linked immunoassay

  4. Fecal short chain fatty acids [ Time Frame: Change from baseline fecal shortchain fatty acids at 30 days ]
    analyzed by gas chromatography


Secondary Outcome Measures :
  1. Blood glucose [ Time Frame: Change from baselineblood glucose at 30 days ]
    analyzed using clinical chemistry analyzer

  2. blood glycated hemoglobin [ Time Frame: Change from baseline blood glycated hemoglobin at 30 days ]
    analyzed using clinical chemistry analyzer

  3. 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

  4. blood insulin level [ Time Frame: Change from baselineblood insulin level at 30 days ]
    analyzed by enzyme-linked immunoassay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT03989882


Contacts
Layout table for location contacts
Contact: Edralin Lucas, PhD (405)744-3132 edralin.a.lucas@okstate.edu
Contact: Sam Emerson, PhD (405)744-2303 sam.emerson@okstate.edu

Locations
Layout table for location information
United States, Oklahoma
Nutritional Sciences Department, Oklahoma State University Recruiting
Stillwater, Oklahoma, United States, 74078
Contact: Edralin Lucas, PhD    405-744-3132    edrali.a.lucas@okstate.edu   
Contact: Sam Emerson, PhD    (405)744-2303    sam.emerson@okstate.edu   
Sponsors and Collaborators
Oklahoma State University
Investigators
Layout table for investigator information
Principal Investigator: Edralin Lucas, PhD Okklahoma State University

Layout table for additonal information
Responsible Party: Oklahoma State University
ClinicalTrials.gov Identifier: NCT03989882     History of Changes
Other Study ID Numbers: HS1888
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oklahoma State University:
wheat germ
overweight
gut microbiome
inflammation
insulin resistance

Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs