High Fiber Bars for Weight Loss

Recruiting at 1 trial location

Overseen By Caryn G Adams, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Must be taking: GLP-1 agonists

Must not be taking: Laxatives, NSAIDs, Probiotics, others

Disqualifiers: GI disorders, Recent GI illness, others

Compensation: Varies

Number of Visits: 5

Duration: 7 days per intervention, 14 days washout

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different high-fiber snack bars to assess their impact on digestion in individuals using weight-loss medications like tirzepatide, semaglutide, or liraglutide. Participants will try three types of high-fiber bars and one low-fiber bar. Researchers aim to determine how these bars affect participants' digestion. Individuals who have used one of these medications for at least four weeks and do not have major digestive issues may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how dietary changes can complement existing weight-loss treatments.

Will I have to stop taking my current medications?

You can continue taking your current GLP-1 agonist medications like tirzepatide, semaglutide, or liraglutide during the study. However, if you use medications or supplements that affect digestion, you may need to stop them for 14 days before starting the trial.

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

Inulin is safe in amounts up to 20 grams per day, though some people might experience minor side effects like gas or bloating. Research has shown that inulin does not cause long-term harm. Studies have also demonstrated that resistant starch type 4 can aid in weight loss and improve gut health, and it is generally well-tolerated in food. High-fiber blends, such as those in the fiber blend bar, have been shown to help lower body weight and improve cholesterol levels. These bars aim to boost health without major side effects. Overall, these high-fiber options are designed to be safe and beneficial for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these high fiber bars for weight loss because they explore new ways to help manage weight using dietary fibers. Unlike traditional weight loss methods like calorie restriction or medication, these bars use specific fibers—Fiber Blend, Inulin, and Resistant Starch type 4—to potentially enhance satiety and improve gut health. Each of these fibers may offer unique benefits: Fiber Blend combines various fibers for a synergistic effect, Inulin serves as a prebiotic promoting healthy gut bacteria, and Resistant Starch type 4 is known for its ability to resist digestion and possibly reduce calorie absorption. These novel approaches could provide a more natural and sustainable option for weight management.

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

This trial will compare different high fiber bars for weight loss. Studies have shown that a high fiber diet can aid in weight loss. The High Fiber Bar with Fiber Blend, which participants in this trial may receive, has been linked to weight loss, with many participants reporting success. Research indicates that the High Fiber Bar with Inulin, another option in this trial, can help manage body weight by lowering body mass index (BMI) and reducing body fat. It also appears to improve gut health, which can support weight management. The High Fiber Bar with Resistant Starch Type 4, also being tested in this trial, has been shown to help reduce body weight and improve insulin handling. Overall, evidence suggests that all three types of high fiber bars may assist with weight loss. ^{2 3 6 7 8}

Who Is on the Research Team?

Kevin C Maki, PhD

Principal Investigator

MB Clinical Research and Consulting LLC

Are You a Good Fit for This Trial?

Adults aged 25-64 using GLP-1 agonists like tirzepatide, semaglutide, or liraglutide for weight loss can join. They must have a BMI of 18.5 to 39.9 and not be on other trials or certain medications that affect GI function. Pregnant women, those with eating disorders, recent surgeries, excessive alcohol intake, or extreme diets cannot participate.

Inclusion Criteria

I have been on tirzepatide, semaglutide, or liraglutide for at least 4 weeks and will continue taking it.

I am between 25 and 64 years old.

Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria

I have not had significant infections or taken antibiotics in the last 10 days.

I have been diagnosed with an eating disorder like anorexia or bulimia.

My doctor thinks I can't safely follow the study or give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 3-day baseline period to assess initial GI symptoms

3 days

1 visit (virtual)

Treatment

Participants consume snack bars containing fiber/fiber blends or control for 7 days each, with a 14-day washout period between interventions

7 days per intervention, 14 days washout

4 visits (virtual)

Follow-up

Participants are monitored for changes in GI symptoms and stool characteristics after each treatment period

14 days

What Are the Treatments Tested in This Trial?

Interventions

• High Fiber bar with Fiber Blend
• High Fiber Bar with Inulin
• High Fiber Bar with Resistant Starch type 4
• Low Fiber Bar

Trial Overview The trial is testing how adults on weight loss meds react to snack bars with different types of fiber: resistant starch type 4, a fiber blend, inulin versus a low-fiber bar over one week each to see which affects gastrointestinal symptoms less.

How Is the Trial Designed?

Group I: Experimental - Resistant Starch Type 4 Experimental Treatment 1 Intervention

Group II: Experimental - Inulin Experimental Treatment 1 Intervention

Group III: Experimental - Fiber Blend Experimental Treatment 1 Intervention

Group IV: Control - Low Fiber Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

22

Recruited

880+

General Mills

Industry Sponsor

Trials

24

Recruited

1,800+

Citations

1. 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 ...

2. withpower.com withpower.com/trial/phase-weight-loss-4-2025-5127d

High Fiber Bars for Weight Loss The objective of this study is to assess self-reported gastrointestinal (GI) responses to three snack bars containing fiber/fiber blends vs. a control snack ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623001470

Daily ingestion of protein bars (with or without added fiber) ... These results suggest that the daily ingestion of protein bars increased overall energy intakes and may impact body mass over time.

4. patlynk.com patlynk.com/trial/NCT07012317

Gastrointestinal Responses to Dietary Fibers in Adults on ... This study explores how different snack bars containing fiber affect the digestive system of adults who are taking GLP-1 agonists, which are medications ...

5. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991%2822%2914394-5/fulltext

Effect of a High-Protein, High-Fiber Beverage Preload on ... In summary, in overweight adults, consuming a beverage with high protein (17 g) and high fiber (6 g) as a preload improved appetite measures of desire to eat, ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/WeightLoss-HealthProfessional/

Dietary Supplements for Weight Loss This fact sheet provides information on weight-loss dietary supplements, including summaries of research on the safety and efficacy of several of the most ...

7. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165%2822%2902702-2/fulltext

Effects of isolated soluble fiber supplementation on body ... Soluble fiber supplementation reduced BMI by 0.84 (95% CI: −1.35, −0.32; P = 0.001), body weight by 2.52 kg (95% CI: −4.25, −0.79 kg; P = 0.004), body fat by ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3405270/

A nutrient-dense, high-fiber, fruit-based supplement bar ... A nutrient-dense, high-fiber, fruit-based supplement bar increases HDL cholesterol, particularly large HDL, lowers homocysteine, and raises glutathione in a 2- ...