Nutritional Supplements in Patients with Anorexia Nervosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-05-22

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.

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oligomeric nutritional formula arm (Bi1 peptidic)

Individuals will receive a Oligomeric nutritional formula.

Group Type EXPERIMENTAL

Experimental Treatment, Oligomeric nutritional formula

Intervention Type OTHER

Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).

Standard arm

Individuals will receive a Standard nutritional formula.

Group Type OTHER

Control Treatment

Intervention Type OTHER

Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).

Interventions

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Experimental Treatment, Oligomeric nutritional formula

Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).

Intervention Type OTHER

Control Treatment

Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).

Intervention Type OTHER

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No