OverweightNCT03989882
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
A study testing Wheat germ energy ball in people with Overweight and Insulin Resistance, run by Oklahoma State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Insulin Resistance, Inflammation
- What is being tested?
- Wheat germ energy ball
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Nutritional Sciences Department, Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
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.
Read the 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.
- Conditions
- Overweight, Insulin Resistance, Inflammation
- Being tested
- Wheat germ energy ball, Control
- Keywords
- wheat germ, overweight, gut microbiome, inflammation, insulin resistance
- Medical subject headings
- Overweight, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat germ energy ballOther
wheat germ mixed other ingredients to make an energy ball
ControlOther
corresponding control without wheat germ
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wheat germ energy ball |
| 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal bacteria population
analyzed by 16sRNA sequencing
Measured: Change from baseline fecal bacteria at 30 days
Fecal immunoglobulin A
analyzed by enzyme-linked immunoassay
Measured: Change from baseline fecal immunoglobulin A at 30 days
Fecal zonulin
analyzed by enzyme-linked immunoassay
Measured: Change from baseline fecal zonulin at 30 days
Fecal short chain fatty acids
analyzed by gas chromatography
Measured: Change from baseline fecal shortchain fatty acids at 30 days
Secondary outcomes (4)
Blood glucose
analyzed using clinical chemistry analyzer
Measured: Change from baselineblood glucose at 30 days
blood glycated hemoglobin
analyzed using clinical chemistry analyzer
Measured: Change from baseline blood glycated hemoglobin at 30 days
blood high sensitivity C-reactive protein
analyzed using clinical chemistry analyzer
Measured: Change from baseline blood high sensitivity C-reactive protein at 30 days
blood insulin level
analyzed by enzyme-linked immunoassay
Measured: Change from baselineblood insulin level at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start28 May 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edralin Lucas, PhD, Principal investigator, Okklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989882
- Sponsor's protocol ID
- HS1888
- Status last verified
- Dec 2021
- First submitted
- 22 May 2019
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38820937
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
- ClinicalTrials.gov ID
- NCT03989882
- Acronym / sponsor ID
- HS1888
- Conditions
- Overweight, Insulin Resistance, Inflammation
- Keywords
- wheat germ, overweight, gut microbiome, inflammation, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat germ | Experimental | Other: Wheat germ energy ballWheat 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 | Other: ControlControl 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat germ energy ballwheat germ mixed other ingredients to make an energy ball | Other | Wheat germ |
| Controlcorresponding control without wheat germ | Other | Control |
Primary outcome
Fecal bacteria population
Time frame: Change from baseline fecal bacteria at 30 days
analyzed by 16sRNA sequencing
Fecal immunoglobulin A
Time frame: Change from baseline fecal immunoglobulin A at 30 days
analyzed by enzyme-linked immunoassay
Fecal zonulin
Time frame: Change from baseline fecal zonulin at 30 days
analyzed by enzyme-linked immunoassay
Fecal short chain fatty acids
Time frame: Change from baseline fecal shortchain fatty acids at 30 days
analyzed by gas chromatography
4 secondary outcomes
Blood glucose
Time frame: Change from baselineblood glucose at 30 days
blood glycated hemoglobin
Time frame: Change from baseline blood glycated hemoglobin at 30 days
blood high sensitivity C-reactive protein
Time frame: Change from baseline blood high sensitivity C-reactive protein at 30 days
blood insulin level
Time frame: Change from baselineblood insulin level at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Derived from this study: PubMed 38820937Dotimas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edralin Lucas, PhD principal investigator
Okklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat germ energy ball in people with Overweight and Insulin Resistance, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal bacteria population (time frame: Change from baseline fecal bacteria at 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.