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

Trial Summary

What is the purpose of this trial?

This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.

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.

Is the dietary intervention for anorexia nervosa generally safe for humans?

The safety of oral food challenges (OFC), which are used to test food tolerance, has been studied in various contexts, including allergies. These studies suggest that OFCs are generally safe when conducted under medical supervision, although they are primarily used for allergy testing rather than dietary interventions for conditions like anorexia nervosa. ^{1 2 3 4 5}

How is the Meal-challenge protocol treatment for anorexia nervosa different from other treatments?

The Meal-challenge protocol is unique because it involves a structured approach to gradually reintroduce and increase food intake, focusing on overcoming food aversions and improving taste responsiveness, which are common issues in anorexia nervosa. This method contrasts with other treatments that may not specifically address these sensory and psychological aspects of eating. ^{6 7 8 9 10}

Research Team

Pei-an (Betty) Shih, MPM, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[SAFETY OF A THREE-LEVEL STEPWISE ORAL FOOD CHALLENGE FOR PEANUT ALLERGY]. [2019]

2. Singapore 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. [2016]

3. India 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Retrospective analysis of 222 oral food challenges with a single dose in acute food protein-induced enterocolitis syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Oral food challenge using different target doses and time intervals between doses. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A one-year follow-up study in anorexia nervosa. Dietary pattern and anthropometrical evolution. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Changes in taste responsiveness in patients with anorexia nervosa during behavior therapy. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The diet composition and nutritional knowledge of patients with anorexia nervosa. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Food preferences and aversions and dietary pattern in anorexia nervosa patients. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Just one more bite: a qualitative analysis of the family meal in family-based treatment for anorexia nervosa. [2018]