Dietary Intervention for Anorexia Nervosa

Recruiting at 1 trial location

Overseen By Pei-an Betty Shih, MPM, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Fish-oil supplements

Disqualifiers: Schizophrenia, Renal disease, Hepatic disease, others

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

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with anorexia nervosa digest and metabolize food differently from those without the condition. Using a meal-challenge protocol (a structured eating test), researchers aim to understand the genetic and biochemical factors affecting food metabolism in anorexia nervosa. The goal is to develop better treatment options for the condition. Ideal participants include individuals with a history of anorexia nervosa, either currently or in the past, and healthy women without any psychiatric illnesses. As an unphased trial, participants contribute to groundbreaking research that may lead to improved treatments for anorexia nervosa.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you regularly use fish-oil supplements.

What prior data suggests that this meal-challenge protocol is safe?

Research has shown that the meal-challenge method used in this study is generally safe. In similar situations, such as the oral food challenge for diagnosing food allergies, this method is usually well-tolerated. Although allergic reactions can occur in those cases, close monitoring ensures any issues are addressed quickly.

For individuals with anorexia nervosa, the meal-challenge method assesses how the body processes food. Previous studies have indicated that this type of research typically does not cause serious side effects. The challenge involves consuming a specific meal, a common practice in studies on eating disorders.

Overall, the meal-challenge method has a safety record suggesting it is well-tolerated by participants. While any medical study can involve risks, this approach has been used safely in similar research settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the meal-challenge protocol for anorexia nervosa because it focuses on a real-world setting, helping patients face challenging eating scenarios in a controlled way. Unlike traditional therapies, which might focus more on psychological counseling or nutritional education, this method directly addresses the anxiety and physiological responses triggered by eating. By replicating meal situations, the protocol could offer insights into managing and reducing the distress associated with eating, potentially leading to more effective coping strategies for individuals with anorexia nervosa.

What evidence suggests that the meal-challenge protocol is effective for anorexia nervosa?

This trial will compare different groups, including individuals with anorexia nervosa and healthy controls, using meal-challenge tests to better understand how people with anorexia nervosa process food. Although these tests typically diagnose food allergies, they might also reveal differences in food metabolism in those with anorexia. This understanding could lead to treatments specifically tailored to their needs. By examining how the body handles food, researchers aim to identify differences between those with anorexia and healthy individuals. Understanding these differences could help develop better treatments by focusing on specific metabolic or biochemical factors. While direct evidence is limited regarding this test's ability to treat anorexia, it offers valuable insights for future therapies. ^{6 7 8 9 10}

Who Is on the Research Team?

Pei-an (Betty) Shih, MPM, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for individuals with anorexia nervosa (AN), including those who have recovered or are currently ill. Recovered participants should have a BMI of 18.5-30 and maintained it for at least a year, while ill participants must meet the DSM V criteria for AN with certain BMI limits. Healthy controls without psychiatric illnesses and stable BMIs are also eligible. People with serious mental health issues, untreated thyroid, kidney or liver diseases, fish-oil supplement use in recent months, or who are pregnant/lactating cannot join.

Inclusion Criteria

I have anorexia as diagnosed by DSM V, with a BMI between 11 and 17.5, or higher with symptoms.

I have or had anorexia but maintained a healthy weight for over a year.

Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.

Exclusion Criteria

I do not have severe mental health issues, untreated thyroid, kidney or liver diseases, and haven't used fish-oil supplements recently. I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meal-Challenge Protocol

Participants undergo a meal-challenge protocol to assess differential metabolism in response to food

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in body weight and psychopathology over time

12 months

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Breakfast sandwich
• Meal-challenge protocol

Trial Overview The study is testing how people with anorexia nervosa metabolize food by having them eat a breakfast sandwich and comparing their responses to healthy controls. It aims to understand the role of genetics and biochemistry in food metabolism within this population to improve treatment approaches.

How Is the Trial Designed?

Group I: Controls Experimental Treatment 1 Intervention

Healthy control women

Group II: Anorexia nervosa II Experimental Treatment 1 Intervention

Anorexia nervosa with BMI \> 18.5 kg/m² for at least 12 months.

Group III: Anorexia nervosa I Experimental Treatment 1 Intervention

Anorexia nervosa with BMI \<=17.5 kg/m² or BMI \>17.5 kg/m² with regular binge-purge episodes

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

The study identified two distinct types of family meals during Maudsley family-based treatment for anorexia nervosa: one where the patient pushed themselves to eat slightly more than they wanted, and another where they complied easily with meal expectations.

The presence of avoidance behaviors from therapists and families during meals was linked to reduced therapeutic effectiveness, suggesting that addressing these avoidance strategies could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just one more bite: a qualitative analysis of the family meal in family-based treatment for anorexia nervosa. Godfrey, K., Rhodes, P., Miskovic-Wheatley, J., et al.[2018]

Low-dose oral food challenges (OFCs) are effective and well tolerated, allowing individuals to maintain some level of food consumption while assessing their tolerance to allergens.

For safety, it is recommended that the time interval between doses during an OFC should be more than 30 minutes, with 1 hour being appropriate to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral food challenge using different target doses and time intervals between doses. Yanagida, N., Sato, S., Nagakura, KI., et al.[2019]

In a study of 17 anorexia nervosa patients, their diets were found to be significantly lower in energy and essential nutrients compared to control subjects, indicating severe nutritional deficiencies during both initial and severe phases of their illness.

Despite having higher nutritional knowledge scores than matched controls, many patients still had inadequate nutrient intakes, particularly for calcium, retinol, and ascorbic acid, suggesting that knowledge alone may not translate into healthier eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diet composition and nutritional knowledge of patients with anorexia nervosa. Beaumont, PJ., Chambers, TL., Rouse, L., et al.[2019]

A study involving 114 patients with peanut allergy demonstrated that a three-level stepwise oral food challenge (OFC) using peanut butter is safe, with only one participant requiring adrenaline during the highest dose.

The OFC showed positive reactions in 52% of participants at the lowest dose (0.1g), decreasing to 20% at the highest dose (3g), indicating that reactions are more common at lower doses, which is important for assessing allergy severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY OF A THREE-LEVEL STEPWISE ORAL FOOD CHALLENGE FOR PEANUT ALLERGY]. Nihei, M., Sato, T., Horino, S., et al.[2019]

The study assessed food intake and eating behaviors in 20 female patients with anorexia nervosa (AN) compared to 20 healthy controls, revealing significant differences in energy intake and food preferences.

Patients with AN reported self-induced vomiting and laxative use, which were not observed in the control groups, highlighting the distinct eating habits and attitudes towards food that can aid in early diagnosis when further validated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food preferences and aversions and dietary pattern in anorexia nervosa patients. Van Binsbergen, CJ., Hulshof, KF., Wedel, M., et al.[2016]

In a study of 199 children who passed oral food challenges (OFC), 71% successfully reintroduced the tested food into their diets without serious adverse reactions, indicating a high safety profile for dietary reintroduction after OFC.

Only 2% of participants reported mild adverse reactions, with no severe reactions observed, suggesting that most children can safely consume previously allergenic foods after passing an OFC, which also improved their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse reactions following a passed oral food challenge and factors affecting successful re-introduction of foods. A retrospective study of a cohort of 199 children. Miceli Sopo, S., Monaco, S., Greco, M., et al.[2016]

In a 1-year study of 14 adolescent patients with anorexia nervosa, significant increases in weight and BMI were observed after one month of treatment, but these improvements were not sustained over time, indicating a tendency to revert to restrictive eating behaviors.

Despite initial increases in energy and macronutrient intake, by the end of the study, negative correlations were found between subcutaneous fat stores and dietary intake, suggesting that patients who gained fat were more likely to return to restrictive eating due to body image dissatisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A one-year follow-up study in anorexia nervosa. Dietary pattern and anthropometrical evolution. Nova, E., Varela, P., López-Vidriero, I., et al.[2004]

Anorexia nervosa patients showed lower taste responsiveness at the start of behavior therapy compared to healthy controls, but this responsiveness significantly improved during treatment (p < 0.01).

The improvement in taste responsiveness occurred before any significant weight gain and was associated with reaching a food intake of 1600 Kcal/day more quickly, suggesting that enhancing taste perception may facilitate better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in taste responsiveness in patients with anorexia nervosa during behavior therapy. Nozoe, S., Masuda, A., Naruo, T., et al.[2019]

In a study of 58 children undergoing oral food challenges (OFCs) over three years, only 5% tested positive for food allergies, indicating that many perceived allergies may not be true allergies.

The OFCs allowed most patients to safely reintroduce previously avoided foods into their diets without serious adverse reactions, highlighting the importance of OFCs in accurately diagnosing food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of oral food challenges in children presenting to a single tertiary centre with perceived or true food allergies. Thalayasingam, M., Loo, EX., Tan, MM., et al.[2022]

In a retrospective analysis of 222 oral food challenges (OFC) for acute food protein-induced enterocolitis syndrome (FPIES), a single full serving size for age was found to be a safe method, with a failure rate of 21.6% and most reactions being mild to moderate.

Patients with a positive skin prick test (SPT) for the tested food experienced more severe reactions, suggesting that starting with a smaller dose for these patients may be a safer approach before administering the full dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of 222 oral food challenges with a single dose in acute food protein-induced enterocolitis syndrome. Miceli Sopo, S., Sinatti, D., Gelsomino, M.[2021]

Citations

1. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

2. foodallergy.org foodallergy.org/resources/oral-food-challenge

Oral Food Challenge This is a highly accurate diagnostic test for food allergies. Safety of Oral Food Challenges. Because this test can cause a serious allergic reaction, only an ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37453573/

Outcomes of oral food challenges in a real-world setting, ... Certain factors can predict tolerating an OFC, and even those considered to be high risk can be safely completed in an outpatient setting, ...

4. jacionline.org jacionline.org/article/S0091-6749(09)00562-4/pdf

Work Group report: Oral food challenge testing history, age, past adverse food reactions, skin prick test (SPT) and serum food-specific IgE test results, and concomitant food allergies. The decision is ...

5. nationwidechildrens.org nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/food-allergy-oral-food-challenge

Food Allergy: Oral Food Challenge An oral food challenge is the single best test used to find out if a child is allergic to a specific food. It is dose-graded.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03100656

Study of Food Aversion in Patients With Anorexia Nervosa | ... This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03100656/study-of-food-aversion-in-patients-with-anorexia-nervosa?page=7&id=13&slug=anorexia

Study of Food Aversion in Patients With Anorexia Nervosa This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in ...

8. commons.emich.edu commons.emich.edu/cgi/viewcontent.cgi?article=2531&context=theses

Predictors of treatment outcome in a family-based ... Obsessive-compulsive features, meal anxiety, gain in percent of expected body weight (EBW), and more parent-reported symptoms were significant ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8500372/

Incidence, prevalence and mortality of anorexia nervosa ... To review the recent literature on the epidemiology of anorexia nervosa and bulimia nervosa in terms of incidence, prevalence and mortality.

10. conehealth.com conehealth.com/app/files/public/c41cb712-9ac9-44e2-ad8e-8240a368e25e/Peds%20Clinical%20Pathways/Eating%20Disorder%20Guidelines%20Feb%202022.pdf

Guidelines for the MEDICAL management of eating disorders These meals range from 550-760 kcal meal. Day 1 provides an average of 1800 kcal/day, Day 2-3 2000-2200 kcal/day. Day 4 provides 760 calorie breakfast ...