NCT06227494

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

July 28, 2023

Last Update Submit

September 23, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Body composition (fat mass, lean mass)

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

  • 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)

  • 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)

  • Total Cholesterol

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

  • Fasting blood glucose

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

  • +9 more secondary outcomes

Study Arms (3)

Fiber Intervention

EXPERIMENTAL

Individuals in this arm will be given instruction on how to increase fiber intake,

Behavioral: Fiber Intervention

Standard Weight Loss Education

ACTIVE COMPARATOR

Individuals in this arm will be given standard weight loss education

Behavioral: Standard Weight Loss Education

Fiber Intervention + Standard Weight Loss Education

EXPERIMENTAL

Individuals in this arm will be given education on both fiber and standard weight loss

Behavioral: Fiber InterventionBehavioral: Standard Weight Loss Education

Interventions

Fiber InterventionBEHAVIORAL

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

Fiber InterventionFiber Intervention + Standard Weight Loss Education
Standard Weight Loss EducationBEHAVIORAL

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

Fiber Intervention + Standard Weight Loss EducationStandard Weight Loss Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

January 29, 2024

Study Start

July 10, 2023

Primary Completion

January 31, 2026

Study Completion

February 28, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)