ObesityNCT05441748
Walnut Consumption and Gut Microbiota
A study testing Walnuts and Walnut Oil in people with Obesity and Inflammation, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- Walnuts and Walnut Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to Jul 2024
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will include adults ages 25-75 years BMI of > 30 kg/m2 Ability to drop-off fecal sample within 15 minutes of defecation
Who cannot join
- Walnut allergy or intolerance
- Food allergies or intolerances
- Prior diagnosis of metabolic or gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
- Women that are pregnant, had a baby within the last 12 months, or lactating
- Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
- > 5% weight change in the past month or > 10% change in the past year
Show all 13Show fewer
- Oral antibiotics during the previous 6 weeks
- Fasting blood glucose >126 mg/dL, blood pressure >160/100 mm Hg, elevation in serum transaminases (i.e. >3 times the upper limit of normal) or with evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation, are currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or certain medications (laxatives, bile acid sequestrants, and opiates)
- History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.
- Are unable to consume the experimental meals/snacks.
- Participants who have donated blood within the last 8 weeks
- Recent diagnosis of anemia
- Concurrent enrollment in another dietary, exercise, or medication study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Microbial and Metabolic Impact of Walnut Consumption in Adults With Obesity
Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. There is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. Since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. The purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. The investigators intention is to identify how these walnut-derived molecules influence Faecalibacterium spp., a butyrate producing microbe. Increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.
- Conditions
- Obesity, Inflammation
- Being tested
- Walnuts, Walnut Oil, Control
- Keywords
- Walnuts, gastrointestinal microbiota, bile acid profiles, inflammation, glycemia, insulinemia
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsOther
The intervention treatment will contain walnuts.
Walnut OilOther
The intervention treatment will contain walnut oil.
ControlOther
The control treatment will contain corn oil.
| Study group | Role | What they receive |
|---|---|---|
| Intervention treatment | Experimental | Intervention treatment will contain walnuts and be consumed everyday for 3 weeks. Receives: Other: Walnuts |
| Intervention treatment oil | Experimental | Intervention treatment will contain walnut oil in foods and be consumed everyday for 3 weeks. Receives: Other: Walnut Oil |
| Control treatment | Placebo comparator | Intervention treatment will contain corn oil in foods and be consumed everyday for 3 weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Microbial Species
Abundances of fecal Faecalibacterium spp. and Roseburia spp measured using metagenomic sequencing in walnut and walnut oil vs. control.
Measured: Fecal samples will be collected at the end of each 3 week condition.
Concentration of fecal bile acids
Fecal bile acid concentrations measured using HPLC in walnut and walnut oil vs. control
Measured: Fecal samples will be collected at the end of each 3 week condition.
Secondary outcomes (1)
Fecal Microbial Metabolites
Concentrations of fecal microbial metabolite (phenol/indoles, short chain fatty acids, and ammonia) concentrations measured using GC-MS in walnut and walnut oil in comparison to a control (corn oil)
Measured: Fecal samples will be collected once at the end of each 3 week condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2022
- Primary completionAug 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Holscher, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441748
- Sponsor's protocol ID
- 20164
- Status last verified
- Jun 2023
- First submitted
- 6 May 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbial and Metabolic Impact of Walnut Consumption in Adults With Obesity
- ClinicalTrials.gov ID
- NCT05441748
- Acronym / sponsor ID
- 20164
- Conditions
- Obesity, Inflammation
- Keywords
- Walnuts, gastrointestinal microbiota, bile acid profiles, inflammation, glycemia, insulinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Jul 2022 (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.
Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. There is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. Since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. The purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. The investigators intention is to identify how these walnut-derived molecules influence Faecalibacterium spp., a butyrate producing microbe. Increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention treatment | Experimental | Other: WalnutsIntervention treatment will contain walnuts and be consumed everyday for 3 weeks. |
| Intervention treatment oil | Experimental | Other: Walnut OilIntervention treatment will contain walnut oil in foods and be consumed everyday for 3 weeks. |
| Control treatment | Placebo comparator | Other: ControlIntervention treatment will contain corn oil in foods and be consumed everyday for 3 weeks. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will include adults ages 25-75 years BMI of > 30 kg/m2 Ability to drop-off fecal sample within 15 minutes of defecation
Key exclusion criteria (13 listed)
- Walnut allergy or intolerance
- Food allergies or intolerances
- Prior diagnosis of metabolic or gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
- Women that are pregnant, had a baby within the last 12 months, or lactating
- Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
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 |
|---|---|---|
| WalnutsThe intervention treatment will contain walnuts. | Other | Intervention treatment |
| Walnut OilThe intervention treatment will contain walnut oil. | Other | Intervention treatment oil |
| ControlThe control treatment will contain corn oil. | Other | Control treatment |
Primary outcome
Fecal Microbial Species
Time frame: Fecal samples will be collected at the end of each 3 week condition.
Abundances of fecal Faecalibacterium spp. and Roseburia spp measured using metagenomic sequencing in walnut and walnut oil vs. control.
Concentration of fecal bile acids
Time frame: Fecal samples will be collected at the end of each 3 week condition.
Fecal bile acid concentrations measured using HPLC in walnut and walnut oil vs. control
1 secondary outcome
Fecal Microbial Metabolites
Time frame: Fecal samples will be collected once at the end of each 3 week condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnuts and Walnut Oil in people with Obesity and Inflammation, run by University of Illinois at Urbana-Champaign 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 13 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
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 Microbial Species (time frame: Fecal samples will be collected at the end of each 3 week condition.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.