Clinical trial NCT05184738: Nutritional Supplements in Patients with Anorexia Nervosa
Official title: Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients with Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
malnutrition
oligomeric formula
polymeric formula
digestive tolerance
body composition
functional capacity
quality of life
anxiety
depression
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: From baseline to week 1
Secondary outcomes:
measure: 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.
timeFrame: From baseline to week 1 in group 1; from baseline to week 8 in group 2
measure: Compare the sensory perception of a polymeric nutritional supplement with respect to an oligomeric one.
timeFrame: From baseline to week 1 in group 1; from baseline to week 8 in group 2
measure: Compare adherence to treatment in group 2 subjects.
timeFrame: From baseline to week 8 in group 2
measure: Evaluate the intake of natural food in group 2 patients.
timeFrame: From baseline to week 8 in group 2
measure: Changes in weight
timeFrame: From baseline to week 8
measure: Change in hand grip strength
timeFrame: From baselilne to week 8
measure: Change in fat mass
timeFrame: From baselilne to week 8
measure: Change in lean mass
timeFrame: From baselilne to week 8
measure: Change in extracellular water
timeFrame: From baselilne to week 8
measure: Change in intracellular water
timeFrame: From baselilne to week 8
measure: Change in phase angle
timeFrame: From baselilne to week 8
measure: Change in total cell mass
timeFrame: From baselilne to week 8
measure: Evaluate the impact of oral nutritional supplementation on the quality of life of the patient
timeFrame: From baselilne to week 8
measure: Changes in eating habits and styles
timeFrame: From baselilne to week 8
measure: Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms.
timeFrame: From baseline to week 8
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
state: Malaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga, FIMABIS
name: Gabriel MD Olveira, PhD
role: PRINCIPAL_INVESTIGATOR
References: