Healthy Nutrition
Conditions
Brief summary
The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are: • Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected. If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.
Interventions
OTHERLow-Processed Food Diet
Participants that receive intervention will be instructed to eat a diet rich in unprocessed/minimally-processed foods, as described by the NOVA food classification system
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* rural county resident * not meeting physical activity guidelines for adults * consuming a typical Western diet (rich in UPF)
Exclusion criteria
* chronic diseases * tobacco, vape, or illicit drug use * overly active * already on a restrictive diet (e.g., keto, intermittent fasting)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 1 year | Using Dual-energy X-ray absorptiometry(DXA), body composition will be assessed |
| Fat-Free Mass Percentage | 1 year | Using Dual-energy X-ray absorptiometry(DXA), fat-free mass will be assessed |
| Fat Mass Percentage | 1 year | Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage will be assessed |
| Body Weight | 1 year | Using a standard scale, body weight in kg will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL | 1 year | Blood draw followed by a Piccolo scan will analyze HDL in the blood |
| Alanine transaminase (ALT) | 1 year | Blood draw followed by a Piccolo scan will analyze ALT in the blood |
| Aspartate transaminase (AST) | 1 year | Blood draw followed by a Piccolo scan will analyze AST in the blood |
| LDL | 1 year | Piccolo scan will analyze LDL in the blood |
| Glucose Levels | 1 year | Blood draw followed by a Piccolo scan will analyze glucose in the blood |
| Cholesterol Levels | 1 year | Blood draw followed by a Piccolo scan will analyze glucose in the blood |
| Triglyceride Levels | 1 year | Blood draw followed by a Piccolo scan will analyze Triglyceride levels in the blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| Energy Intake | 1 year | 3-Day Food Logs will record caloric intake at various points |
| Gut Microbiome Collection | 1 year | Stool kits administered for fecal collection will be used for gut microbiome collection |
| Energy Expenditure | 1 year | Resting Metabolic Rate will be used to find resting energy expenditure and an accelerometer will measure expended energy through fitness, combined these will show energy expenditure |
Countries
United States
Outcome results
None listed