Nutritional Supplements in Patients With Anorexia Nervosa

Study Overview
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Brief Summary
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Anorexia nervosa causes gastroparesis, constipation, and can lead to elevated liver enzymes. It is often necessary to supplement the diet of patients with nutritional formulas. The ingestion of a peptide formula, with partially hydrolyzed protein and rich in medium chain triglycerides, could favor its digestion and absorption, improving its tolerance and acceptance by the patient, compared to a polymeric formula.

Detailed Description
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Main objective: • To compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit. Secondary Objectives: Assess the gastrointestinal tolerance of the oral nutritional supplement on a single occasion with respect to a continuous intake over a period of 4 weeks. Evaluate the impact of oral nutritional supplementation on nutritional status over a four-week period. Evaluate the impact of oral nutritional supplementation on the functional capacity of the patient in a period of four weeks. Evaluate the impact of oral nutritional supplementation on the patient's body composition over a four-week period. Evaluate the impact of oral nutritional supplementation on the quality of life of the patient in a period of four weeks. Evaluate the impact of oral nutritional supplementation on the depressive and anxious symptoms of the patient in a period of four weeks.

Official Title
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Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients With Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Experimental Treatment, Oligomeric nutritional formula
* Other: Control Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants, ≥ 12 y ≤ 40 years of age at screening Diagnosed of Anorexy nervous according to DSM-5 Appropiate cultural level & understanding of the clinical study To be in agreement in participate voluntarily in the study and written informed consent must be obtained from the participants. Females who are non-pregnant and non-lactating women or women who have given birth at least six weeks before to the screening visit. Exclusion Criteria: Allergy or intolerance to any component of the products under study. Participation in a concomitant trial that conflicts with this study Doesn't sign the informed consent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oligomeric nutritional formula arm (Bi1 peptidic)<br>Individuals will receive a Oligomeric nutritional formula. | Other: Experimental Treatment, Oligomeric nutritional formula<br>* Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).<br>|
| Other: Standard arm<br>Individuals will receive a Standard nutritional formula. | Other: Control Treatment<br>* Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit. | Differences in the score of the questionnaire: Evaluation questionnaire for gastrointestinal complaints. This questionnaire assesses the presence (and where appropriate its degree) or absence of nausea, vomiting, diarrhea, constipation, reflux or heartburn. Each section has a score from 0 to 10, which will be filled in by the patient himself. | From baseline to week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the gastrointestinal tolerance of the oral nutritional supplement on a single occasion with respect to a continuous intake over a period of 4 weeks. | Difference in score in the questionnaire Evaluation questionnaire for gastrointestinal complaints. This questionnaire assesses the presence (and where appropriate its degree) or absence of nausea, vomiting, diarrhea, constipation, reflux or heartburn. Each section has a score from 0 to 10, which will be filled in by the patient himself. | From baseline to week 1 in group 1; from baseline to week 8 in group 2 | 
| Compare the sensory perception of a polymeric nutritional supplement with respect to an oligomeric one. | Change in the score of the Product sensory evaluation questionnaire. It consists of 11 items, which assess how the patient perceives the organoleptic characteristics of the product and their satisfaction after taking it. Each item consists of a score from 0 to 10 that the patient has to fill in. The items can refer to positive or negative characteristics of the product, so the level of score in each of them can indicate better or worse characteristics of the product depending on the characteristic in question. | From baseline to week 1 in group 1; from baseline to week 8 in group 2 | 
| Compare adherence to treatment in group 2 subjects. | Adherence will be determined by daily registration of the percentage they take of the supplement. | From baseline to week 8 in group 2 | 
| Evaluate the intake of natural food in group 2 patients. | Dietary registration of natural food intake at breakfast, mid-morning snack and lunch, in group 2 patients. It will be done through the DIETSTAT program. The total amount of calories and the percentage of macronutrients will be determined. | From baseline to week 8 in group 2 | 
| Changes in weight | Weight will be measured in kg | From baseline to week 8 | 
| Change in hand grip strength | It will be determined with a JAMAR dynamometer. The mean and maximum of three measurements made on the dominant hand and the mean and maximum of three measurements made on the non-dominant hand will be taken. The outside will be measured in kg. | From baselilne to week 8 | 
| Change in fat mass | Determined by AKERN bioimpedance analyzer and measured in kg | From baselilne to week 8 | 
| Change in lean mass | Determined by AKERN bioimpedance meter and measured in kg | From baselilne to week 8 | 
| Change in extracellular water | Determined by AKERN bioimpedance analyzer and measured in l | From baselilne to week 8 | 
| Change in intracellular water | Determined by AKERN bioimpedance analyzer and measured in l | From baselilne to week 8 | 
| Change in phase angle | Determined by AKERN bioimpedance analyzer and measured in degrees of angle | From baselilne to week 8 | 
| Change in total cell mass | Determined by AKERN bioimpedance analyzer and measured in kg | From baselilne to week 8 | 
| Evaluate the impact of oral nutritional supplementation on the quality of life of the patient | Changes in the score of the SF-12 Health Questionnaire questionnaire. This questionnaire is the adaptation made for Spain of the SF-12 Health Survey. The SF-12 is a shortened version of the SF-36 Health Questionnaire designed for uses where it is too long. Provides a health status profile. It consists of 12 items from the 8 dimensions of the SF-36 Physical Function (2), Social Function (1), Physical role (2), Emotional role (2), Mental health (2), Vitality (1), Body pain (1), General Health (1). The response options form Likert-type scales that assess intensity or frequency. The number of answer options ranges from three to six, depending on the item. For each of the 8 dimensions, the items are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status). | From baselilne to week 8 | 
| Changes in eating habits and styles | Changes in the score of the Eating Disorder Examination-Q (EDE-Q) test. This questionnaire takes about 10 minutes to complete. It studies the scope and severity of the characteristics associated with the diagnosis of eating disorder. It includes 4 subscales: Restriction-diet, Preoccupation with food, Preoccupation with weight and Concern about the figure. Includes a definition of the term binge (eg, episodes in which you have eaten an abnormally large amount of food under the circumstances and experiencing a loss of control over eating). The EDE-Q generates two types of data: frequency data on key behavioral features of eating disorders in terms of number of episodes of the behavior, and subscale scores reflecting the severity of characteristics of eating disorders. Higher scores on the global scale and subscales denote more problematic eating behaviors and attitudes. | From baselilne to week 8 | 
| Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms. | Changes in the score of the Hospital Anxiety and Depression Scale (HADS). This aims to detect depressive and anxiety disorders in non-psychiatric hospital services, avoiding overlap with symptoms due to physical illness, without taking into account the physical aspects that may accompany anxiety / depression, only affecting the emotional ones. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, patients can be classified as normal (<7), doubtful (between 8 and 10) and potential clinical case (≥ 11). The score is referred to the last week. | From baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia nervosa, malnutrition, oligomeric formula, polymeric formula, digestive tolerance, body composition, functional capacity, quality of life, anxiety, depression