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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06227494
• Other study ID #: IRB-23-59-STW
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2024
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: February 28, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Fiber Intervention
Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.
• Standard Weight Loss Education
Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Measure of body weight/mass	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Body composition (fat mass, lean mass)	Dual x-ray absorptiometry (DEXA) scans	Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)
Secondary	Fecal short chain fatty acids	Taken from fecal samples collected at home	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing	Will include measures of diversity, abundance, etc.	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Total Cholesterol	Measured via blood samples (unit= milligram/deciliter (mg/dL))	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Fasting blood glucose	Measured via blood samples (unit=mg/dL)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)
Secondary	Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)	Taken from 3 day diet records (score range=0-100, higher=better diet quality)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Three-Factor Eating Questionnaire	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	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Implicit Association Test	Represented with a total D variable (No range, but more negative = greater preference for unprocessed food)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale	Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Executive Function: Tower Test (Delis-Kaplan Executive Function System)	Total Achievement Score (range=0-30, higher = higher executive function)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)	Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Skin Carotenoid scores measured via the Veggie Meter	Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	High-density lipoprotein (HDL) cholesterol	Measured via blood samples (unit=mg/dL)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary	Low-density lipoprotein (LDL) cholesterol	Measured via blood samples (unit=mg/dL)	Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)