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NCT Number: NCT06227494

Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?

The overall objective of this three-arm randomized controlled trial is to compare a dietary fiber-focused behavioral intervention to standard weight loss education for improving eating-related behavior and cognition, weight, and metabolic markers of chronic disease risk in a population of adults with obesity.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 years of age
  • Dietary fiber intake ≤25 grams/day
  • Self-reported BMI ≥30 kg/m2
  • Willingness to attend in-person education sessions
  • Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®),
  • Willingness to provide informed consent.

Exclusion criteria

  • Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis)
  • History of gastric bypass surgery
  • Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists
  • Self-reported history of a diagnosed eating disorder
  • Chronic disease (other than obesity)
  • Pregnancy or lactation
  • Use of tobacco or electronic smoking products
  • Taking a pre-, pro-, or syn-biotic supplement
  • Enrollment in another weight loss or diet intervention

Treatment and study plan

Fiber Intervention

Behavioral

Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.

Standard Weight Loss Education

Behavioral

Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.

Primary outcomes

  1. Body weight

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Measure of body weight/mass

Secondary outcomes

  1. Body composition (fat mass, lean mass)

    Time frame: Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)

    Dual x-ray absorptiometry (DEXA) scans

  2. Fecal short chain fatty acids

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Taken from fecal samples collected at home

  3. Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Will include measures of diversity, abundance, etc.

  4. Total Cholesterol

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Measured via blood samples (unit= milligram/deciliter (mg/dL))

  5. Fasting blood glucose

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)

    Measured via blood samples (unit=mg/dL)

  6. Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Taken from 3 day diet records (score range=0-100, higher=better diet quality)

  7. Three-Factor Eating Questionnaire

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Resulting scores in uncontrolled eating (range=9-36), cognitive restraint (range=3-12), and emotional eating (range=6-24); higher scores indicate more of that particular eating behavior

  8. Implicit Association Test

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Represented with a total D variable (No range, but more negative = greater preference for unprocessed food)

  9. Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation

  10. Executive Function: Tower Test (Delis-Kaplan Executive Function System)

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Total Achievement Score (range=0-30, higher = higher executive function)

  11. Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)

  12. Skin Carotenoid scores measured via the Veggie Meter

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables)

  13. High-density lipoprotein (HDL) cholesterol

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Measured via blood samples (unit=mg/dL)

  14. Low-density lipoprotein (LDL) cholesterol

    Time frame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)

    Measured via blood samples (unit=mg/dL)

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Sep 29, 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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