Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
40

Summary

Conditions
  • Inflammation
  • Insulin Resistance
  • Overweight
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Participants will not know their treatment assignment and energy balls will be in an opaque container.Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 45 years
Gender
Both males and females

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 e...

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.

Tracking Information

NCT #
NCT03989882
Collaborators
Not Provided
Investigators
Principal Investigator: Edralin Lucas, PhD Okklahoma State University