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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989882
Other study ID # HS1888
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2019
Est. completion date November 30, 2021

Study information

Verified date December 2021
Source Oklahoma State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Wheat germ energy ball
wheat germ mixed other ingredients to make an energy ball
Control
corresponding control without wheat germ

Locations

Country Name City State
United States Nutritional Sciences Department, Oklahoma State University Stillwater Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fecal bacteria population analyzed by 16sRNA sequencing Change from baseline fecal bacteria at 30 days
Primary Fecal immunoglobulin A analyzed by enzyme-linked immunoassay Change from baseline fecal immunoglobulin A at 30 days
Primary Fecal zonulin analyzed by enzyme-linked immunoassay Change from baseline fecal zonulin at 30 days
Primary Fecal short chain fatty acids analyzed by gas chromatography Change from baseline fecal shortchain fatty acids at 30 days
Secondary Blood glucose analyzed using clinical chemistry analyzer Change from baselineblood glucose at 30 days
Secondary blood glycated hemoglobin analyzed using clinical chemistry analyzer Change from baseline blood glycated hemoglobin at 30 days
Secondary blood high sensitivity C-reactive protein analyzed using clinical chemistry analyzer Change from baseline blood high sensitivity C-reactive protein at 30 days
Secondary blood insulin level analyzed by enzyme-linked immunoassay Change from baselineblood insulin level at 30 days
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