Clinical trial NCT03989882: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Insulin Resistance
Inflammation
Keywords: wheat germ
overweight
gut microbiome
inflammation
insulin resistance
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Fecal bacteria population
timeFrame: Change from baseline fecal bacteria at 30 days
measure: Fecal immunoglobulin A
timeFrame: Change from baseline fecal immunoglobulin A at 30 days
measure: Fecal zonulin
timeFrame: Change from baseline fecal zonulin at 30 days
measure: Fecal short chain fatty acids
timeFrame: Change from baseline fecal shortchain fatty acids at 30 days
Secondary outcomes:
measure: Blood glucose
timeFrame: Change from baselineblood glucose at 30 days
measure: blood glycated hemoglobin
timeFrame: Change from baseline blood glycated hemoglobin at 30 days
measure: blood high sensitivity C-reactive protein
timeFrame: Change from baseline blood high sensitivity C-reactive protein at 30 days
measure: blood insulin level
timeFrame: Change from baselineblood insulin level at 30 days
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Nutritional Sciences Department, Oklahoma State University
state: Oklahoma
Study officials:
affiliation: Okklahoma State University
name: Edralin Lucas, PhD
role: PRINCIPAL_INVESTIGATOR
References: