Inflammation Clinical Trial
Official title:
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
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 |
Verified date | December 2021 |
Source | Oklahoma State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Nutritional Sciences Department, Oklahoma State University | Stillwater | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma State University |
United States,
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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