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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989882
• Other study ID #: HS1888
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Overweight

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