Inflammation, Insulin Resistance, Overweight
Conditions
Keywords
wheat germ, overweight, gut microbiome, inflammation, insulin resistance
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.
Interventions
OTHERWheat germ energy ball
wheat germ mixed other ingredients to make an energy ball
OTHERControl
corresponding control without wheat germ
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will not know their treatment assignment and energy balls will be in an opaque container.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal short chain fatty acids | Change from baseline fecal shortchain fatty acids at 30 days | analyzed by gas chromatography |
| Fecal bacteria population | Change from baseline fecal bacteria at 30 days | analyzed by 16sRNA sequencing |
| Fecal immunoglobulin A | Change from baseline fecal immunoglobulin A at 30 days | analyzed by enzyme-linked immunoassay |
| Fecal zonulin | Change from baseline fecal zonulin at 30 days | analyzed by enzyme-linked immunoassay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose | Change from baselineblood glucose at 30 days | analyzed using clinical chemistry analyzer |
| blood glycated hemoglobin | Change from baseline blood glycated hemoglobin at 30 days | analyzed using clinical chemistry analyzer |
| blood high sensitivity C-reactive protein | Change from baseline blood high sensitivity C-reactive protein at 30 days | analyzed using clinical chemistry analyzer |
| blood insulin level | Change from baselineblood insulin level at 30 days | analyzed by enzyme-linked immunoassay |
Countries
United States
Outcome results
None listed