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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat germ energy ball | Other | wheat germ mixed other ingredients to make an energy ball |
| |
| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Edralin Lucas, PhD | Okklahoma State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutritional Sciences Department, Oklahoma State University | Stillwater | Oklahoma | 74078 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38820937 | Derived | Dotimas LG, Ojo B, Kaur A, Alake S, Dixon M, Rassi GD, Ice JA, Zhao J, Emerson SR, Smith BJ, Lucas EA. Wheat germ supplementation has modest effects on gut health markers but improves glucose homeostasis markers in adults classified as overweight: A randomized controlled pilot study. Nutr Res. 2024 Jul;127:13-26. doi: 10.1016/j.nutres.2024.05.001. Epub 2024 May 4. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Participants will not know their treatment assignment and energy balls will be in an opaque container.
| Control |
| Other |
corresponding control without wheat germ |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |