Nutritional Supplements in Patients with Anorexia Nervosa (PEPTIDICAN21)

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

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Other: Control Treatment; Other: Experimental Treatment, Oligomeric nutritional formula

Study type: Interventional

Funder types: Other

Identifiers

NCT05184738

PEPTIDIC-AN-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Oligomeric nutritional formula arm (Bi1 peptidic)

Experimental group

Description:

Individuals will receive a Oligomeric nutritional formula.

Treatment:

Other: Experimental Treatment, Oligomeric nutritional formula

Standard arm

Other group

Description:

Individuals will receive a Standard nutritional formula.

Treatment:

Other: Control Treatment