Healthy Nutrition
Conditions
Keywords
Animal-based, Plant-based, Microbiome, Hydrogen sulfide, Ulcerative colitis
Brief summary
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.
Interventions
BEHAVIORALPlant-Based Diet then animal-based diet
Participants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days.
BEHAVIORALAnimal-based diet then plant-based diet
Participants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days
Sponsors
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
5-week crossover pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide informed consent * Ambulatory and community dwelling * Able and willing to comply with the study schedule and procedures * 18 - 80 years of age * BMI between 18.5 - 40.0 kg/m2 * Omnivorous or willing to consume animal products through duration of study
Exclusion criteria
* Antibiotic use within 3 months * Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics. * Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results * Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis * History of anaphylactic food allergies, e.g., peanuts, seafood. * Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content. * Strict vegan eating practices, with refusal to consume animal products. * Planned use of oral probiotics while on study. * Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation. * Significant alcohol use, defined as \> 20 g/day in females and \> 30 g/day in males for a period of 3 months within one year prior to screening. * Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease. * History of partial or complete colectomy. * History of malabsorptive bariatric surgery. * Currently participating in another clinical study. * Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production | Following 1-week of plant- and animal-based eating patterns | Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plant-based Then Animal Based plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources
Participants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days. | 7 |
| Animal-based Then Plant Based plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources
Participants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Pandemic | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Plant-based Then Animal Based | Animal-based Then Plant Based | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool
Time frame: Following 1-week of plant- and animal-based eating patterns
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plant-based Diet | Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production | 69 ppm hydrogen sulfide gas |
| Animal-based Diet | Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production | 103 ppm hydrogen sulfide gas |