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

Oklahoma State University

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Fiber Intervention; Behavioral: Standard Weight Loss Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06227494

IRB-23-59-STW

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Fiber Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Fiber Intervention

Standard Weight Loss Education

Active Comparator group

Description:

Individuals in this arm will be given standard weight loss education

Treatment:

Behavioral: Standard Weight Loss Education

Fiber Intervention + Standard Weight Loss Education

Experimental group

Description:

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

Treatment:

Behavioral: Fiber Intervention

Behavioral: Standard Weight Loss Education