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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight, Insulin Resistance, Inflammation

Intervention / Treatment
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* Other: Wheat germ energy ball
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat germ<br>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<br>* wheat germ mixed other ingredients to make an energy ball<br>|
| Placebo Comparator: Control<br>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<br>* corresponding control without wheat germ<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheat germ, overweight, gut microbiome, inflammation, insulin resistance