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Walnut Consumption and Gut Microbiota

The Microbial and Metabolic Impact of Walnut Consumption in Adults With Obesity

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05441748
Enrollment
30
Registered
2022-07-01
Start date
2022-06-01
Completion date
2024-07-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Inflammation

Keywords

Walnuts, gastrointestinal microbiota, bile acid profiles, inflammation, glycemia, insulinemia

Brief 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. 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.

Interventions

OTHERWalnuts

The intervention treatment will contain walnuts.

The intervention treatment will contain walnut oil.

OTHERControl

The control treatment will contain corn oil.

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Participants will include adults ages 25-75 years BMI of \> 30 kg/m2 Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Fecal Microbial SpeciesFecal 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 acidsFecal 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

Secondary

MeasureTime frameDescription
Fecal Microbial MetabolitesFecal samples will be collected once at the end of each 3 week condition.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)

Other

MeasureTime frameDescription
Mixed-meal tolerance testAt the end of each 3 week condition.Blood glucose and insulin concentrations and area under the curve will be measured in blood during a mixed meal tolerance test that includes a standard glucose beverage and the respective walnut, walnut oil, or corn oil treatment.
Fecal MicrobiomeFecal samples will be collected at the end of each 3 week condition.Relative abundance of microbial genes and genera measured using metagenomic sequencing of extracted fecal DNA to compare abundances between walnut, walnut oil, and corn oil.
Intestinal permeability24-hour urine collections will occur at the end of each 3 week conditionIntestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.
Inflammatory markersBlood samples will be collected at the end of each 3 week condition.LPS-binding protein and inflammatory markers (CRP and TNFa) concentrations in walnut and walnut oil vs. control (corn oil)
Serum bile acid profilesBlood samples will be collected during a mixed-meal tolerance test that occurs at the end of each 3 week condition.Serum bile acid concentrations will be measured using LC-ESI-MS/MS to compare concentrations between walnut and walnut oil and control (corn oil)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026