Nutritional Supplements in Patients with Anorexia Nervosa

NCT05184738 | Completed

• 1 other identifier: PEPTIDIC-AN-2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; malnutrition; oligomeric formula; polymeric formula; digestive tolerance; body composition; functional capacity; quality of life; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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.

  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.

  From baseline to week 1 in group 1; from baseline to week 8 in group 2

• Compare adherence to treatment in group 2 subjects.

  From baseline to week 8 in group 2

• Evaluate the intake of natural food in group 2 patients.

  From baseline to week 8 in group 2

• Changes in weight

  From baseline to week 8

Study Arms (2)

Oligomeric nutritional formula arm (Bi1 peptidic)

EXPERIMENTAL

Individuals will receive a Oligomeric nutritional formula.

Other: Experimental Treatment, Oligomeric nutritional formula

Standard arm

OTHER

Individuals will receive a Standard nutritional formula.

Other: Control Treatment

Interventions

Experimental Treatment, Oligomeric nutritional formula OTHER

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

Oligomeric nutritional formula arm (Bi1 peptidic)

Control Treatment OTHER

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

Standard arm

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, MALAGA, 29009, Spain

Location

Related Publications (1)

• Ruiz Garcia I, Porras Perez N, Garcia Torres F, Olivas Delgado L, Sanchez Torralvo FJ, Pascual Lopez M, Fernandez Marzalo C, Olveira G. Comparison of the digestive tolerance of an oligomeric versus a polymeric oral nutritional supplement in people with anorexia nervosa. A randomised crossover clinical trial. Eur J Clin Nutr. 2025 Aug;79(8):780-786. doi: 10.1038/s41430-025-01608-y. Epub 2025 Mar 31.

  PMID: 40164776 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Malnutrition; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Gabriel MD Olveira, PhD

  Hospital Regional Universitario de Málaga, FIMABIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 11, 2022
• Study Start: October 15, 2021
• Primary Completion: March 12, 2022
• Study Completion: May 22, 2022
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

ES (1)