Nutritional Sciences Department, Oklahoma State University
Stillwater, Oklahoma, 74078, United States
NCT Number: NCT03989882
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Stillwater, Oklahoma, 74078, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
wheat germ mixed other ingredients to make an energy ball
corresponding control without wheat germ
Time frame: Change from baseline fecal bacteria at 30 days
analyzed by 16sRNA sequencing
Time frame: Change from baseline fecal immunoglobulin A at 30 days
analyzed by enzyme-linked immunoassay
Time frame: Change from baseline fecal zonulin at 30 days
analyzed by enzyme-linked immunoassay
Time frame: Change from baseline fecal shortchain fatty acids at 30 days
analyzed by gas chromatography
Time frame: Change from baselineblood glucose at 30 days
analyzed using clinical chemistry analyzer
Time frame: Change from baseline blood glycated hemoglobin at 30 days
analyzed using clinical chemistry analyzer
Time frame: Change from baseline blood high sensitivity C-reactive protein at 30 days
analyzed using clinical chemistry analyzer
Time frame: Change from baselineblood insulin level at 30 days
analyzed by enzyme-linked immunoassay
Oklahoma State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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