NCT05184738

Nutritional Supplements in Patients with Anorexia Nervosa

Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients with Anorexia Nervosa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
OTHER	Experimental Treatment, Oligomeric nutritional formula	Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).
OTHER	Control Treatment	Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-03-12
• Completion: 2022-05-22
• First posted: 2022-01-11
• Last updated: 2025-02-14

Locations

1 site across 1 country: Spain