Fiber Intervention for Obesity

Overseen By Ashlea Braun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Must not be taking: GLP-1 agonists, Prebiotics

Disqualifiers: Metabolic conditions, Gastric bypass, Eating disorder, Chronic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if increasing fiber intake can help individuals with obesity improve eating habits, lose weight, and reduce long-term health risks. Participants will be divided into three groups: one will learn about increasing fiber and general weight loss, another will focus solely on fiber (Fiber Intervention), and the last group will receive standard weight loss advice. This trial suits adults with obesity who consume 25 grams or less of fiber daily and are willing to attend in-person sessions. As an unphased trial, it offers a unique opportunity to contribute to understanding how dietary changes affect obesity and overall health.

Will I have to stop taking my current medications?

The trial requires that you stop taking glucagon-like peptide-1 (GLP-1) Receptor Agonists and any pre-, pro-, or syn-biotic supplements. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that increasing dietary fiber is generally safe for most people. In one study, adding fiber supplements to a healthy diet helped people lose weight without major side effects. Another study found that eating more fiber over 16 weeks was linked to weight loss, with the amount of fiber consumed strongly predicting weight loss.

One study found that consuming at least 20.8 grams of fiber daily was associated with a 26% lower chance of obesity. In another study, 116 participants engaged in a program that included fiber education and regular check-ins. Over two years, this approach helped them lose weight safely.

Overall, these studies suggest that increasing fiber intake is well-tolerated and can aid in weight loss. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for obesity because they focus on increasing fiber intake, which can be a game-changer in weight management. Unlike the usual approach that often relies on calorie restriction and exercise, the fiber intervention emphasizes the natural benefits of dietary fiber, known to promote feelings of fullness and improve gut health. This could offer a more sustainable and health-conscious way to tackle obesity, potentially leading to long-term weight loss without the drastic lifestyle changes that other methods require. By integrating fiber education into standard weight loss advice, this approach could provide a more holistic and effective strategy for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that increasing dietary fiber intake can aid weight loss and improve health in individuals with obesity. For instance, one study found that people consuming at least 20.8 grams of fiber daily were 26% less likely to be obese. Another report indicated that adding soluble fiber improved weight and health in overweight adults. Further evidence demonstrated that a fiber-focused program resulted in weight loss for about 62.5% of participants over 16 weeks. This trial will assess the effectiveness of a Fiber Intervention, with some participants receiving only fiber-focused education, while others receive both Fiber Intervention and Standard Weight Loss Education. These studies suggest that fiber plays a crucial role in a successful weight loss plan and can help manage weight and improve health. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with obesity who are interested in improving their eating habits, weight, and health markers related to chronic diseases. Participants must meet certain criteria set by the researchers but these specific requirements are not provided here.

Inclusion Criteria

Willingness to provide informed consent.

I am willing to not take any digestive aid supplements.

Dietary fiber intake ≤25 grams/day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a dietary fiber-focused behavioral intervention or standard weight loss education

15 months

Regular visits for intervention and monitoring

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Fiber Intervention
• Standard Weight Loss Education

Trial Overview The study is testing whether focusing on dietary fiber can help people change their behavior and improve health more than just getting standard weight loss advice. It's a three-part test where participants are randomly assigned to one of the groups.

How Is the Trial Designed?

Group I: Fiber Intervention + Standard Weight Loss Education Experimental Treatment 2 Interventions

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

Group II: Fiber Intervention Experimental Treatment 1 Intervention

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

Group III: Standard Weight Loss Education Active Control 1 Intervention

Individuals in this arm will be given standard weight loss education

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Published Research Related to This Trial

In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a weight reduction of at least 10%.

Patients who voluntarily discharged themselves showed the largest decrease in BMI (12.8), highlighting the importance of personal motivation in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. Díaz Gómez, J., Armero Fuster, M., Calvo Viñuela, I., et al.[2013]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

High-fiber diets, which include non-starchy vegetables, fruits, whole grains, legumes, and nuts, are linked to better body-weight regulation and increased feelings of fullness, making them potentially effective for preventing and treating obesity in children.

In addition to aiding in weight management, fiber-rich diets may also help prevent cardiovascular disease and type 2 diabetes, offering further health benefits beyond just weight control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and body-weight regulation. Observations and mechanisms. Pereira, MA., Ludwig, DS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12277132/

Association between dietary fiber intake and obesity in US ... After adjusting for confounders, dietary fiber intake in the quartile 4 (≥ 20.8 g/day) was linked with a 26% lower incidence of obesity than ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522027022

Effects of isolated soluble fiber supplementation on body ... Isolated soluble fiber supplementation improves anthropometric and metabolic outcomes in overweight and obese adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10150096/

Increased dietary fiber is associated with weight loss ... The initial finding confirms that the 16-week FPL program results in weight loss among the majority of participants, with 62.5% reporting ...

4. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/articles/10.1186/s12944-025-02659-7

Protein, fiber, and exercise: a narrative review of their roles in ... This narrative review summarizes the evidence for the roles of increasing protein, fiber, and exercise for weight management and improving the cardiometabolic ...

5. nutrition.org nutrition.org/dietary-fiber-an-integral-component-of-a-successful-weight-loss-intervention/

Dietary fiber: An integral component of a successful weight ... Results of this study strongly suggest that dietary fiber intake is an integral component of a successful dietary weight loss intervention that involves ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8714052/

A Retrospective, Observational Study to Assess the ... Dietary fiber supplemental combination with proper diet therapy/modification was found to be safe and effective in causing significant weight reduction in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622164503

Fiber Intake Predicts Weight Loss and Dietary Adherence ... Dietary fiber intake, independently of macronutrient and caloric intake, promotes weight loss and dietary adherence in adults with overweight or obesity ...

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1602600/full

Association between dietary fiber intake and obesity in US ... Results: After adjusting for confounders, dietary fiber intake in the quartile 4 (≥ 20.8 g/day) was linked with a 26% lower incidence of obesity ...

9. withpower.com withpower.com/trial/fiber-intervention-for-obesity-a1fd4

Fiber Intervention for Obesity · Info for Participants In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a ...