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

Not Applicable

Active, not recruiting

• Conditions: Obesity

• Registration Number: NCT06227494
• Lead Sponsor: Oklahoma State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-01-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-01-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Body weight	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 Outcome Measures

Name	Time	Method
Total Cholesterol	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))
Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing	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.
Fasting blood glucose	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)
Executive Function: Tower Test (Delis-Kaplan Executive Function System)	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)
Low-density lipoprotein (LDL) cholesterol	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)
Body composition (fat mass, lean mass)	Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)	Dual x-ray absorptiometry (DEXA) scans
Three-Factor Eating Questionnaire	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
Implicit Association Test	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)
Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale	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
Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)	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)
Skin Carotenoid scores measured via the Veggie Meter	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)
High-density lipoprotein (HDL) cholesterol	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)
Fecal short chain fatty acids	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
Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)	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)

Trial Locations

Locations (1)

Oklahoma State University; 🇺🇸 Stillwater, Oklahoma, United States