Back to resultsWalnut Consumption and Gut Microbiota
Primary Purpose
Obesity, Inflammation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walnuts
Walnut Oil
Control
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Walnuts, gastrointestinal microbiota, bile acid profiles, inflammation, glycemia, insulinemia
Eligibility Criteria
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
Sites / Locations
- Hannah Holscher
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Intervention treatment
Intervention treatment oil
Control treatment
Arm Description
Intervention treatment will contain walnuts and be consumed everyday for 3 weeks.
Intervention treatment will contain walnut oil in foods and be consumed everyday for 3 weeks.
Intervention treatment will contain corn oil in foods and be consumed everyday for 3 weeks.
Outcomes
Primary Outcome Measures
Fecal Microbial Species
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 bile acid concentrations measured using HPLC in walnut and walnut oil vs. control
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05441748
First Posted
May 6, 2021
Last Updated
June 15, 2023
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT05441748
Brief Title
Walnut Consumption and Gut Microbiota
Official Title
The Microbial and Metabolic Impact of Walnut Consumption in Adults With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation
Keywords
Walnuts, gastrointestinal microbiota, bile acid profiles, inflammation, glycemia, insulinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention treatment
Arm Type
Experimental
Arm Description
Intervention treatment will contain walnuts and be consumed everyday for 3 weeks.
Arm Title
Intervention treatment oil
Arm Type
Experimental
Arm Description
Intervention treatment will contain walnut oil in foods and be consumed everyday for 3 weeks.
Arm Title
Control treatment
Arm Type
Placebo Comparator
Arm Description
Intervention treatment will contain corn oil in foods and be consumed everyday for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Walnuts
Intervention Description
The intervention treatment will contain walnuts.
Intervention Type
Other
Intervention Name(s)
Walnut Oil
Intervention Description
The intervention treatment will contain walnut oil.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control treatment will contain corn oil.
Primary Outcome Measure Information:
Title
Fecal Microbial Species
Description
Abundances of fecal Faecalibacterium spp. and Roseburia spp measured using metagenomic sequencing in walnut and walnut oil vs. control.
Time Frame
Fecal samples will be collected at the end of each 3 week condition.
Title
Concentration of fecal bile acids
Description
Fecal bile acid concentrations measured using HPLC in walnut and walnut oil vs. control
Time Frame
Fecal samples will be collected at the end of each 3 week condition.
Secondary Outcome Measure Information:
Title
Fecal Microbial Metabolites
Description
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)
Time Frame
Fecal samples will be collected once at the end of each 3 week condition.
Other Pre-specified Outcome Measures:
Title
Fecal Microbiome
Description
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.
Time Frame
Fecal samples will be collected at the end of each 3 week condition.
Title
Inflammatory markers
Description
LPS-binding protein and inflammatory markers (CRP and TNFa) concentrations in walnut and walnut oil vs. control (corn oil)
Time Frame
Blood samples will be collected at the end of each 3 week condition.
Title
Serum bile acid profiles
Description
Serum bile acid concentrations will be measured using LC-ESI-MS/MS to compare concentrations between walnut and walnut oil and control (corn oil)
Time Frame
Blood samples will be collected during a mixed-meal tolerance test that occurs at the end of each 3 week condition.
Title
Mixed-meal tolerance test
Description
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.
Time Frame
At the end of each 3 week condition.
Title
Intestinal permeability
Description
Intestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.
Time Frame
24-hour urine collections will occur at the end of each 3 week condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hannah Holscher
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
12. IPD Sharing Statement
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Walnut Consumption and Gut Microbiota
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