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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Overweight; Insulin Resistance
• Intervention / Treatment: Other: Wheat germ energy ball; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Nutritional Sciences Department, Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wheat germ; Wheat germ energy balls containing 30 g of wheat germ, peanut butter, and honey to form 2 energy balls that is approximately 200 kcal. Two energy balls will be consumed daily for 30 days.	Other: Wheat germ energy ball; wheat germ mixed other ingredients to make an energy ball
Placebo Comparator: Control; Control energy ball containing 30 g of cornmeal, peanut butter, and honey to form 2 energy balls that is approximately 200 kcal. Two energy balls will be consumed daily for 30 days.	Other: Control; corresponding control without wheat germ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal bacteria population	analyzed by 16sRNA sequencing	Change from baseline fecal bacteria at 30 days
Fecal immunoglobulin A	analyzed by enzyme-linked immunoassay	Change from baseline fecal immunoglobulin A at 30 days
Fecal zonulin	analyzed by enzyme-linked immunoassay	Change from baseline fecal zonulin at 30 days
Fecal short chain fatty acids	analyzed by gas chromatography	Change from baseline fecal shortchain fatty acids at 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose	analyzed using clinical chemistry analyzer	Change from baselineblood glucose at 30 days
blood glycated hemoglobin	analyzed using clinical chemistry analyzer	Change from baseline blood glycated hemoglobin at 30 days
blood high sensitivity C-reactive protein	analyzed using clinical chemistry analyzer	Change from baseline blood high sensitivity C-reactive protein at 30 days
blood insulin level	analyzed by enzyme-linked immunoassay	Change from baselineblood insulin level at 30 days

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Investigators: Principal Investigator: Edralin Lucas, PhD, Okklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: overweight; inflammation; insulin resistance; gut microbiome; wheat germ
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperinsulinism; Inflammation; Insulin Resistance; Overweight
• Other Study ID Numbers: HS1888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No