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

Oklahoma State University

Status: Completed

Conditions: Inflammation; Overweight; Insulin Resistance

Treatments: Other: Control; Other: Wheat germ energy ball

Study type: Interventional

Funder types: Other

Identifiers

NCT03989882

HS1888

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Wheat germ

Experimental group

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.

Treatment:

Other: Wheat germ energy ball

Control

Placebo Comparator group

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.

Treatment:

Other: Control