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Completed

NCT Number: NCT03989882

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutritional Sciences Department, Oklahoma State University

Stillwater, Oklahoma, 74078, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wheat germ energy ball

Other

wheat germ mixed other ingredients to make an energy ball

Control

Other

corresponding control without wheat germ

Primary outcomes

  1. Fecal bacteria population

    Time frame: Change from baseline fecal bacteria at 30 days

    analyzed by 16sRNA sequencing

  2. Fecal immunoglobulin A

    Time frame: Change from baseline fecal immunoglobulin A at 30 days

    analyzed by enzyme-linked immunoassay

  3. Fecal zonulin

    Time frame: Change from baseline fecal zonulin at 30 days

    analyzed by enzyme-linked immunoassay

  4. Fecal short chain fatty acids

    Time frame: Change from baseline fecal shortchain fatty acids at 30 days

    analyzed by gas chromatography

Secondary outcomes

  1. Blood glucose

    Time frame: Change from baselineblood glucose at 30 days

    analyzed using clinical chemistry analyzer

  2. blood glycated hemoglobin

    Time frame: Change from baseline blood glycated hemoglobin at 30 days

    analyzed using clinical chemistry analyzer

  3. blood high sensitivity C-reactive protein

    Time frame: Change from baseline blood high sensitivity C-reactive protein at 30 days

    analyzed using clinical chemistry analyzer

  4. blood insulin level

    Time frame: Change from baselineblood insulin level at 30 days

    analyzed by enzyme-linked immunoassay

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2019
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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