Clinical trial NCT06227494: Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
Official title: Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Secondary outcomes:
measure: Body composition (fat mass, lean mass)
timeFrame: Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)
measure: Fecal short chain fatty acids
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Total Cholesterol
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Fasting blood glucose
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)
measure: Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Three-Factor Eating Questionnaire
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Implicit Association Test
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Executive Function: Tower Test (Delis-Kaplan Executive Function System)
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Skin Carotenoid scores measured via the Veggie Meter
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References: