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

NCT03989882 | Completed

• 1 other identifier: HS1888
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Insulin Resistance; Inflammation

Keywords

wheat germ; overweight; gut microbiome; inflammation; insulin resistance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Blood glucose

  Change from baselineblood glucose at 30 days

• blood glycated hemoglobin

  Change from baseline blood glycated hemoglobin at 30 days

• blood high sensitivity C-reactive protein

  Change from baseline blood high sensitivity C-reactive protein at 30 days

• blood insulin level

  Change from baselineblood insulin level at 30 days

Study Arms (2)

Wheat germ

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Wheat germ energy ball OTHER

wheat germ mixed other ingredients to make an energy ball

Wheat germ

Control OTHER

corresponding control without wheat germ

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Nutritional Sciences Department, Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Overweight; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• Edralin Lucas, PhD

  Okklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know their treatment assignment and energy balls will be in an opaque container.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 18, 2019
• Study Start: May 28, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)