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Nutritional Supplements in Patients With Anorexia Nervosa (PEPTIDICAN21)

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Treatment, Oligomeric nutritional formula
Control Treatment
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, malnutrition, oligomeric formula, polymeric formula, digestive tolerance, body composition, functional capacity, quality of life, anxiety, depression

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Regional Universitario de Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Oligomeric nutritional formula arm (Bi1 peptidic)

Standard arm

Arm Description

Individuals will receive a Oligomeric nutritional formula.

Individuals will receive a Standard nutritional formula.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Compare adherence to treatment in group 2 subjects.
Adherence will be determined by daily registration of the percentage they take of the supplement.
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.
Changes in weight
Weight will be measured in kg
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.
Change in fat mass
Determined by AKERN bioimpedance analyzer and measured in kg
Change in lean mass
Determined by AKERN bioimpedance meter and measured in kg
Change in extracellular water
Determined by AKERN bioimpedance analyzer and measured in l
Change in intracellular water
Determined by AKERN bioimpedance analyzer and measured in l
Change in phase angle
Determined by AKERN bioimpedance analyzer and measured in degrees of angle
Change in total cell mass
Determined by AKERN bioimpedance analyzer and measured in kg
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).
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.
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.

Full Information

First Posted
December 2, 2021
Last Updated
July 1, 2022
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05184738
Brief Title
Nutritional Supplements in Patients With Anorexia Nervosa
Acronym
PEPTIDICAN21
Official Title
Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, malnutrition, oligomeric formula, polymeric formula, digestive tolerance, body composition, functional capacity, quality of life, anxiety, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oligomeric nutritional formula arm (Bi1 peptidic)
Arm Type
Experimental
Arm Description
Individuals will receive a Oligomeric nutritional formula.
Arm Title
Standard arm
Arm Type
Other
Arm Description
Individuals will receive a Standard nutritional formula.
Intervention Type
Other
Intervention Name(s)
Experimental Treatment, Oligomeric nutritional formula
Intervention Description
Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).
Intervention Type
Other
Intervention Name(s)
Control Treatment
Intervention Description
Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
From baseline to week 1
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
From baseline to week 1 in group 1; from baseline to week 8 in group 2
Title
Compare the sensory perception of a polymeric nutritional supplement with respect to an oligomeric one.
Description
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.
Time Frame
From baseline to week 1 in group 1; from baseline to week 8 in group 2
Title
Compare adherence to treatment in group 2 subjects.
Description
Adherence will be determined by daily registration of the percentage they take of the supplement.
Time Frame
From baseline to week 8 in group 2
Title
Evaluate the intake of natural food in group 2 patients.
Description
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.
Time Frame
From baseline to week 8 in group 2
Title
Changes in weight
Description
Weight will be measured in kg
Time Frame
From baseline to week 8
Title
Change in hand grip strength
Description
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.
Time Frame
From baselilne to week 8
Title
Change in fat mass
Description
Determined by AKERN bioimpedance analyzer and measured in kg
Time Frame
From baselilne to week 8
Title
Change in lean mass
Description
Determined by AKERN bioimpedance meter and measured in kg
Time Frame
From baselilne to week 8
Title
Change in extracellular water
Description
Determined by AKERN bioimpedance analyzer and measured in l
Time Frame
From baselilne to week 8
Title
Change in intracellular water
Description
Determined by AKERN bioimpedance analyzer and measured in l
Time Frame
From baselilne to week 8
Title
Change in phase angle
Description
Determined by AKERN bioimpedance analyzer and measured in degrees of angle
Time Frame
From baselilne to week 8
Title
Change in total cell mass
Description
Determined by AKERN bioimpedance analyzer and measured in kg
Time Frame
From baselilne to week 8
Title
Evaluate the impact of oral nutritional supplementation on the quality of life of the patient
Description
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).
Time Frame
From baselilne to week 8
Title
Changes in eating habits and styles
Description
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.
Time Frame
From baselilne to week 8
Title
Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms.
Description
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.
Time Frame
From baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel MD Olveira, PhD
Organizational Affiliation
Hospital Regional Universitario de Málaga, FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

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Nutritional Supplements in Patients With Anorexia Nervosa

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