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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study seeks to recruit 25 participants who meet program criteria by alleviating chronic morbidities that plague this region by providing participants with nutritional food boxes partnered with nutrition education classes to determine impact and potential benefits of using food as medicine. The key measures seeking to be examined in the program are reducing food insecurity, healthy food consumption, increased nutrition education, and a decrease in biometrics such as hypertension, A1C levels, hyperlipidemia indices, and obesity. UAMS East seeks to alleviate chronic morbidities and food insecurity by launching a food-as-medicine program called The Good Food Rx. The Good Food Rx Program couples established nutrition education classes participation with, at the same time, providing healthy curated nutritional food boxes to at-risk individuals.

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 data supports the effectiveness of the treatment 'Food as medicine' for obesity?

Research suggests that effective obesity management involves a combination of diet, exercise, and lifestyle changes. While specific diets can lead to initial weight loss, maintaining these changes over time is crucial for long-term success. ^{1 2 3 4 5}

Is the 'Food as Medicine' approach for obesity generally safe for humans?

The safety of using food as medicine for obesity isn't well-documented, and many weight loss supplements and herbal products can have unpredictable and potentially harmful effects. Some products may contain toxic herbs or undisclosed ingredients, leading to adverse reactions, so it's important to be cautious and consult healthcare professionals before use. ^{6 7 8 9 10}

How does the 'Food as Medicine' treatment for obesity differ from other treatments?

The 'Food as Medicine' treatment for obesity is unique because it focuses on using specific dietary changes to create a calorie deficit while ensuring adequate intake of essential nutrients like proteins and vitamins. Unlike pharmacological interventions that may have side effects, this approach emphasizes natural dietary adjustments to manage energy balance and promote satiety. ^{11 12 13 14 15}

Research Team

Amber K Norris, MD

Principal Investigator

UAMS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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

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Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. [2022]

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