Food as Medicine for Obesity

Overseen By Amber K Norris, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Healthy individuals, others

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

Compensation: Varies

Number of Visits: 26

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether food can serve as medicine to manage chronic health issues such as high blood pressure, high blood sugar, high cholesterol, and obesity. Participants will attend nutrition classes and receive monthly boxes of healthy food and recipes. The goal is to determine if these resources can improve health and reduce food insecurity. This trial suits patients of UAMS East Family Medical Center in Helena, Arkansas, who struggle with these chronic conditions. As an unphased trial, it provides a unique opportunity for patients to explore innovative dietary approaches to enhance their health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding nutrition education and food boxes rather than changing medication use.

What prior data suggests that this food-as-medicine approach is safe?

Research has shown that using food to improve health is generally safe for most people. In a large study, providing fresh fruits and vegetables improved health without major safety issues. Another review examined various programs and found that participants were satisfied with the food they received, and their health improved over time. These findings suggest that this approach is well-tolerated.

Overall, using food to boost health appears to be a safe choice. Participants in similar programs have experienced positive changes without significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "food as medicine" approach for obesity because it offers a fresh perspective on treatment. Unlike traditional medical treatments that often involve medication or surgery, this method uses nutrition education and provides participants with a nutrition box and recipes to guide healthy eating habits. This approach not only targets weight loss but also empowers individuals to make sustainable lifestyle changes by understanding how food can directly impact their health. By focusing on education and practical dietary changes, this treatment could offer a more natural and less invasive alternative to current options.

What evidence suggests that using food as medicine could be effective for obesity?

Research has shown that using "food as medicine" can help manage obesity and related health issues. A large study found that adults on low-carb diets lost about 6.8 kg on average. Additionally, certain proteins in food may help control fat cell growth, supporting weight management. Another study found that participants reduced their body mass index (BMI) and improved their eating habits, such as consuming less salt and sugar. While some programs increased participation in preventive health care, they did not always improve blood sugar levels, indicating the need for personalized plans. These findings suggest that using food wisely can benefit those dealing with obesity and related conditions. In this trial, participants will attend monthly nutrition education sessions and receive a free nutrition box with recipes, exploring the "food as medicine" approach. ^{4 6 7 8 9}

Who Is on the Research Team?

Amber K Norris, MD

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

The Good Food Rx program is for adults over 18 with chronic health issues like high blood pressure, diabetes (high A1C levels), high cholesterol (hyperlipidemia), or obesity. They must be patients at UAMS East Family Medical Center in Helena, Arkansas. Healthy individuals and those under 18 are not eligible.

Inclusion Criteria

I have a chronic condition like high blood pressure, diabetes, high cholesterol, or obesity.

A patient at UAMS East Family Medical Center in Helena, Arkansas

Exclusion Criteria

I am generally healthy without chronic conditions like high blood pressure, diabetes, high cholesterol, or obesity.

I am older than 17.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Initial Assessment

Participants sign consent forms and complete a pre-assessment nutritional profile

1 week

1 visit (in-person)

Active Study Phase

Participants attend bi-monthly nutrition education classes and receive nutritional food boxes

12 months

24 visits (in-person or virtual)

Follow-up

Participants' routine laboratory data is collected for comparison to the active study phase

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Food as medicine

Trial Overview This pilot study tests the impact of providing nutritional food boxes along with nutrition education classes on improving health outcomes. It aims to reduce food insecurity and improve biometrics such as blood pressure, A1C levels, cholesterol indices, and weight in participants.

How Is the Trial Designed?

Group I: Educational sessions plus a nutrition box and recipes Experimental Treatment 1 Intervention

Monthly nutrition education sessions will be attended by the subjects and then each subject will receive a free nutrition box that includes recipes that pertain to the food contents in the prepackaged box

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Arkansas Community Foundation

Collaborator

Trials

1

Recruited

20+

USDA Beltsville Human Nutrition Research Center

Collaborator

Trials

56

Recruited

5,300+

Well Fed

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Herbal anti-obesity products are popular due to their perceived safety and health claims, but they can contain harmful ingredients like toxic herbs and undisclosed adulterants, leading to unpredictable and potentially dangerous effects.

Healthcare professionals should educate patients about the risks associated with these products, including possible toxicity and adverse interactions with other medications, and report any adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential risks associated with the use of herbal anti-obesity products. Chan, TY.[2021]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

A study analyzing 66 reports of adverse reactions to dietary supplements for weight control found that 64% of these reactions were serious, indicating significant safety concerns associated with their use.

The most commonly affected systems included the cardiovascular (26%) and gastrointestinal (17%) systems, highlighting the potential risks of self-medicating with these herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions associated with herbal products used for weight loss: spontaneous reports from the Italian Phytovigilance System. Mazzanti, G., Vitalone, A., Da Cas, R., et al.[2021]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Obesity is a growing health concern in the U.S., affecting both children and adults, and requires a comprehensive treatment approach that includes diet, exercise, and behavioral changes for long-term management.

Health professionals play a crucial role in promoting healthy lifestyle choices, preventing obesity-related health issues, and guiding patients towards safe and effective weight loss and maintenance programs, supported by recent evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity: assessment and management in primary care. Lyznicki, JM., Young, DC., Riggs, JA., et al.[2022]

Weight loss supplements in the U.S. are not regulated as drugs by the FDA, which means they undergo minimal testing for safety and efficacy, leading to potential risks for consumers.

Healthcare providers need to be aware of the lack of evidence supporting the effectiveness of these supplements and advocate for better regulatory oversight to protect consumers from unproven and possibly harmful products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplements and alternative therapies for obesity: A Perspective from The Obesity Society's Clinical Committee. Kidambi, S., Batsis, JA., Donahoo, WT., et al.[2021]

Obesity significantly increases the risk of various health issues, including hypertension, diabetes, and heart disease, yet many physicians feel unprepared to address this widespread problem among U.S. adults.

Effective management strategies for obesity include recommending self-management techniques, advising on diets and commercial weight-loss programs, prescribing medications like sibutramine and orlistat alongside lifestyle changes, and considering bariatric surgery for individuals with severe obesity or related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-based strategies for the management of obesity. Rao, G.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9908371/

Food as Medicine for Obesity Treatment and Management A large meta-analysis of adults with obesity concluded that low-carbohydrate diets (<40% of total energy) promote a 6.8 kg decrease in body weight on average ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291822001527

Food as Medicine for Obesity Treatment and Management Bioactive peptides (BAPs) derived from food proteins have shown promise as safe and effective anti-obesity agents by regulating adipocyte differentiation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051899/

Food is Medicine: The Effectiveness of Delaware's Feeding ... Participants demonstrated significant reductions in BMI and improved dietary behaviors, including decreased consumption of sodium, sugar, and ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2812982

Effect of an Intensive Food-as-Medicine Program on Health ... In this randomized clinical trial, an intensive food-as-medicine program increased engagement with preventive health care but did not improve glycemic control.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... This is the largest produce prescription study to date to assess health outcomes, pooling data across 22 program locations in the United States.

7. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.00585

'Food Is Medicine' In The US: A National Survey Of Public ... Each year in the US, poor nutrition causes more than 600,000 deaths and an estimated $1.1 trillion in preventable health care spending and lost ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9032066/

Food as medicine? Exploring the impact of providing healthy ... The impact of adherence to provided diets reduced lab values and resulted in reduced cardiovascular events, including stroke. These results illustrate the ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0735109723083171

“Food Is Medicine” Strategies for Nutrition Security and ... Pre/post analyses at 6 months demonstrated >80% program satisfaction, an 18% absolute decrease in food insecurity, 2-point drop in BMI, 9% decrease in obesity, ...