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

N/AActive Not RecruitingNCT06227494

Oklahoma State University63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Fiber InterventionBEHAVIORAL

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oklahoma State University

Stillwater, Oklahoma, United States

Outcomes

Primary Outcomes

Body weight

Measure of body weight/mass

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

Secondary Outcomes

Body composition (fat mass, lean mass)

Dual x-ray absorptiometry (DEXA) scans

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

Fecal short chain fatty acids

Taken from fecal samples collected at home

Time frame: 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

Will include measures of diversity, abundance, etc.

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

Total Cholesterol

Measured via blood samples (unit= milligram/deciliter (mg/dL))

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

Fasting blood glucose

Measured via blood samples (unit=mg/dL)

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

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)

Data from ClinicalTrials.gov

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