Walnut Consumption and Gut Microbiota

Not Applicable

Active, not recruiting

• Conditions: Inflammation; Obesity
• Interventions: Other: Walnuts; Other: Walnut Oil; Other: Control

• Registration Number: NCT05441748
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-08
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention treatment	Walnuts	Intervention treatment will contain walnuts and be consumed everyday for 3 weeks.
Intervention treatment oil	Walnut Oil	Intervention treatment will contain walnut oil in foods and be consumed everyday for 3 weeks.
Control treatment	Control	Intervention treatment will contain corn oil in foods and be consumed everyday for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Fecal Microbial Species	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	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

Secondary Outcome Measures

Name	Time	Method
Fecal Microbial Metabolites	Fecal 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)

Trial Locations

Locations (1)

Hannah Holscher; 🇺🇸 Urbana, Illinois, United States