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

Primary Purpose

Overweight, Insulin Resistance, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wheat germ energy ball
Control
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring wheat germ, overweight, gut microbiome, inflammation, insulin resistance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nutritional Sciences Department, Oklahoma State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wheat germ

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fecal bacteria population
analyzed by 16sRNA sequencing
Fecal immunoglobulin A
analyzed by enzyme-linked immunoassay
Fecal zonulin
analyzed by enzyme-linked immunoassay
Fecal short chain fatty acids
analyzed by gas chromatography

Secondary Outcome Measures

Blood glucose
analyzed using clinical chemistry analyzer
blood glycated hemoglobin
analyzed using clinical chemistry analyzer
blood high sensitivity C-reactive protein
analyzed using clinical chemistry analyzer
blood insulin level
analyzed by enzyme-linked immunoassay

Full Information

First Posted
May 22, 2019
Last Updated
December 6, 2021
Sponsor
Oklahoma State University
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1. Study Identification

Unique Protocol Identification Number
NCT03989882
Brief Title
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Official Title
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Insulin Resistance, Inflammation
Keywords
wheat germ, overweight, gut microbiome, inflammation, insulin resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will not know their treatment assignment and energy balls will be in an opaque container.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wheat germ
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Wheat germ energy ball
Intervention Description
wheat germ mixed other ingredients to make an energy ball
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
corresponding control without wheat germ
Primary Outcome Measure Information:
Title
Fecal bacteria population
Description
analyzed by 16sRNA sequencing
Time Frame
Change from baseline fecal bacteria at 30 days
Title
Fecal immunoglobulin A
Description
analyzed by enzyme-linked immunoassay
Time Frame
Change from baseline fecal immunoglobulin A at 30 days
Title
Fecal zonulin
Description
analyzed by enzyme-linked immunoassay
Time Frame
Change from baseline fecal zonulin at 30 days
Title
Fecal short chain fatty acids
Description
analyzed by gas chromatography
Time Frame
Change from baseline fecal shortchain fatty acids at 30 days
Secondary Outcome Measure Information:
Title
Blood glucose
Description
analyzed using clinical chemistry analyzer
Time Frame
Change from baselineblood glucose at 30 days
Title
blood glycated hemoglobin
Description
analyzed using clinical chemistry analyzer
Time Frame
Change from baseline blood glycated hemoglobin at 30 days
Title
blood high sensitivity C-reactive protein
Description
analyzed using clinical chemistry analyzer
Time Frame
Change from baseline blood high sensitivity C-reactive protein at 30 days
Title
blood insulin level
Description
analyzed by enzyme-linked immunoassay
Time Frame
Change from baselineblood insulin level at 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edralin Lucas, PhD
Organizational Affiliation
Okklahoma State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutritional Sciences Department, Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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