NCT03989882

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Oklahoma State University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Insulin Resistance
• Inflammation

Interventions

Type	Name	Description
OTHER	Wheat germ energy ball	wheat germ mixed other ingredients to make an energy ball
OTHER	Control	corresponding control without wheat germ

Timeline

• Start date: 2019-05-28
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2019-06-18
• Last updated: 2021-12-07

Locations

1 site across 1 country: United States