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Active, Not Recruiting

NCT Number: NCT06310603

Determinants and Outcomes of High vs. Low Ultra-processed Feeding

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Nutrition

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for Applied Nutrition and Exercise Science (LANES)

Stillwater, Oklahoma, 74075, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low-Processed Food Diet

Other

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

Primary outcomes

  1. Body Weight

    Time frame: 1 year

    Using a standard scale, body weight in kg will be assessed

  2. Body Composition

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), body composition will be assessed

  3. Fat Mass Percentage

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage will be assessed

  4. Fat-Free Mass Percentage

    Time frame: 1 year

    Using Dual-energy X-ray absorptiometry(DXA), fat-free mass will be assessed

Secondary outcomes

  1. Triglyceride Levels

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze Triglyceride levels in the blood

  2. Glucose Levels

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze glucose in the blood

  3. Cholesterol Levels

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze glucose in the blood

  4. HDL

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze HDL in the blood

  5. LDL

    Time frame: 1 year

    Piccolo scan will analyze LDL in the blood

  6. Alanine transaminase (ALT)

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze ALT in the blood

  7. Aspartate transaminase (AST)

    Time frame: 1 year

    Blood draw followed by a Piccolo scan will analyze AST in the blood

Other outcomes

  1. Energy Intake

    Time frame: 1 year

    3-Day Food Logs will record caloric intake at various points

  2. Energy Expenditure

    Time frame: 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

  3. Gut Microbiome Collection

    Time frame: 1 year

    Stool kits administered for fecal collection will be used for gut microbiome collection

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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