Anorexia NervosaPEPTIDICAN21NCT05184738
Nutritional Supplements in Patients with Anorexia Nervosa
A study testing Experimental Treatment, Oligomeric nutritional formula in people with Anorexia Nervosa, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Experimental Treatment, Oligomeric nutritional formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2021to 22 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients with Anorexia Nervosa
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.
Read the 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
- Being tested
- Experimental Treatment, Oligomeric nutritional formula, Control Treatment
- Keywords
- Anorexia nervosa, malnutrition, oligomeric formula, polymeric formula, digestive tolerance, body composition, functional capacity, quality of life, anxiety, depression
- Medical subject headings
- Anorexia Nervosa, Malnutrition, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Treatment, Oligomeric nutritional formulaOther
Intervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain).
Control TreatmentOther
Standard nutritional formula (isocaloric and isoprotein compared to the experimental treatment).
| Study group | Role | What they receive |
|---|---|---|
| Oligomeric nutritional formula arm (Bi1 peptidic) | Experimental | Individuals will receive a Oligomeric nutritional formula. Receives: Other: Experimental Treatment, Oligomeric nutritional formula |
| Standard arm | Other | Individuals will receive a Standard nutritional formula. Receives: Other: Control Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Difference in score in 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.
Measured: 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.
Change in the score of the "Product sensory evaluation questionnaire". It consists of 11 items, which assess how the patient perceives the organoleptic characteristics of the product and their satisfaction after taking it. Each item consists of a score from 0 to 10 that the patient has to fill in. The items can refer to positive or negative characteristics of the product, so the level of score in each of them can indicate better or worse characteristics of the product depending on the characteristic in question.
Measured: From baseline to week 1 in group 1; from baseline to week 8 in group 2
Compare adherence to treatment in group 2 subjects.
Adherence will be determined by daily registration of the percentage they take of the supplement.
Measured: From baseline to week 8 in group 2
Evaluate the intake of natural food in group 2 patients.
Dietary registration of natural food intake at breakfast, mid-morning snack and lunch, in group 2 patients. It will be done through the DIETSTAT program. The total amount of calories and the percentage of macronutrients will be determined.
Measured: From baseline to week 8 in group 2
Changes in weight
Weight will be measured in kg
Measured: From baseline to week 8
Change in hand grip strength
It will be determined with a JAMAR dynamometer. The mean and maximum of three measurements made on the dominant hand and the mean and maximum of three measurements made on the non-dominant hand will be taken. The outside will be measured in kg.
Measured: From baselilne to week 8
Change in fat mass
Determined by AKERN bioimpedance analyzer and measured in kg
Measured: From baselilne to week 8
Change in lean mass
Determined by AKERN bioimpedance meter and measured in kg
Measured: From baselilne to week 8
Change in extracellular water
Determined by AKERN bioimpedance analyzer and measured in l
Measured: From baselilne to week 8
Change in intracellular water
Determined by AKERN bioimpedance analyzer and measured in l
Measured: From baselilne to week 8
Change in phase angle
Determined by AKERN bioimpedance analyzer and measured in degrees of angle
Measured: From baselilne to week 8
Change in total cell mass
Determined by AKERN bioimpedance analyzer and measured in kg
Measured: From baselilne to week 8
Evaluate the impact of oral nutritional supplementation on the quality of life of the patient
Changes in the score of the "SF-12 Health Questionnaire" questionnaire. This questionnaire is the adaptation made for Spain of the SF-12 Health Survey. The SF-12 is a shortened version of the SF-36 Health Questionnaire designed for uses where it is too long. Provides a health status profile. It consists of 12 items from the 8 dimensions of the SF-36 Physical Function (2), Social Function (1), Physical role (2), Emotional role (2), Mental health (2), Vitality (1), Body pain (1), General Health (1). The response options form Likert-type scales that assess intensity or frequency. The number of answer options ranges from three to six, depending on the item. For each of the 8 dimensions, the items are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
Measured: From baselilne to week 8
Changes in eating habits and styles
Changes in the score of the "Eating Disorder Examination-Q (EDE-Q)" test. This questionnaire takes about 10 minutes to complete. It studies the scope and severity of the characteristics associated with the diagnosis of eating disorder. It includes 4 subscales: Restriction-diet, Preoccupation with food, Preoccupation with weight and Concern about the figure. Includes a definition of the term "binge" (eg, "episodes in which you have eaten an abnormally large amount of food under the circumstances" and experiencing a "loss of control" over eating). The EDE-Q generates two types of data: frequency data on key behavioral features of eating disorders in terms of number of episodes of the behavior, and subscale scores reflecting the severity of characteristics of eating disorders. Higher scores on the global scale and subscales denote more problematic eating behaviors and attitudes.
Measured: From baselilne to week 8
Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms.
Changes in the score of the "Hospital Anxiety and Depression Scale (HADS)". This aims to detect depressive and anxiety disorders in non-psychiatric hospital services, avoiding overlap with symptoms due to physical illness, without taking into account the physical aspects that may accompany anxiety / depression, only affecting the emotional ones. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, patients can be classified as normal (<7), doubtful (between 8 and 10) and potential clinical case (≥ 11). The score is referred to the last week.
Measured: From baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Oct 2021
- Primary completion12 Mar 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel MD Olveira, PhD, Principal investigator, Hospital Regional Universitario de Málaga, FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184738
- Sponsor's protocol ID
- PEPTIDIC-AN-2021
- Acronym
- PEPTIDICAN21
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40164776
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance of Two Oral Nutritional Supplements in Patients with Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05184738
- Acronym / sponsor ID
- PEPTIDICAN21 / PEPTIDIC-AN-2021
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, malnutrition, oligomeric formula, polymeric formula, digestive tolerance, body composition, functional capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligomeric nutritional formula arm (Bi1 peptidic) | Experimental | Other: Experimental Treatment, Oligomeric nutritional formulaIndividuals will receive a Oligomeric nutritional formula. |
| Standard arm | Other | Other: Control TreatmentIndividuals will receive a Standard nutritional formula. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Treatment, Oligomeric nutritional formulaIntervention group will receive a oligomeric nutritional formula (Bi1 peptidic Adventia Pharma, Spain). | Other | Oligomeric nutritional formula arm (Bi1 peptidic) |
| Control TreatmentStandard nutritional formula (isocaloric and isoprotein compared to the experimental treatment). | Other | Standard arm |
Primary outcome
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.
Time frame: From baseline to week 1
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.
15 secondary outcomes
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.
Time frame: 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.
Time frame: From baseline to week 1 in group 1; from baseline to week 8 in group 2
Compare adherence to treatment in group 2 subjects.
Time frame: From baseline to week 8 in group 2
Evaluate the intake of natural food in group 2 patients.
Time frame: From baseline to week 8 in group 2
Changes in weight
Time frame: From baseline to week 8
Change in hand grip strength
Time frame: From baselilne to week 8
Change in fat mass
Time frame: From baselilne to week 8
Change in lean mass
Time frame: From baselilne to week 8
Change in extracellular water
Time frame: From baselilne to week 8
Change in intracellular water
Time frame: From baselilne to week 8
Change in phase angle
Time frame: From baselilne to week 8
Change in total cell mass
Time frame: From baselilne to week 8
Evaluate the impact of oral nutritional supplementation on the quality of life of the patient
Time frame: From baselilne to week 8
Changes in eating habits and styles
Time frame: From baselilne to week 8
Assess the impact of oral nutritional supplementation on the patient's depressive and anxious symptoms.
Time frame: From baseline to week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Derived from this study: PubMed 40164776Ruiz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel MD Olveira, PhD principal investigator
Hospital Regional Universitario de Málaga, FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Treatment, Oligomeric nutritional formula in people with Anorexia Nervosa, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From baseline to week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.