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Clinical Trials/NCT06227494
NCT06227494Active, not recruitingNot Applicable

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

Oklahoma State University2 sites in 1 country63 target enrollmentStarted: July 10, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
63
Locations
2
Primary Endpoint
Body weight
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • Total Cholesterol(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))
  • Fasting blood glucose(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27))
  • 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))
  • 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))
  • Body composition (fat mass, lean mass)(Measured at baseline (time 1, month 0) and post-observation (time 3, month 27))
  • Three-Factor Eating Questionnaire(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
  • Implicit Association Test(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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