NCT05689710

Brief Summary

The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 23, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 30, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

December 23, 2022

Last Update Submit

December 23, 2025

Conditions

Metabolic SyndromeCardiac Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days

Secondary Outcomes (2)

  • Tryglicerides

    Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days

  • Hypertension

    Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days

Study Arms (2)

No intervention

NO INTERVENTION

Experimental

EXPERIMENTAL

Dietary Supplement with inositols and alpha-lactalbumin

Dietary Supplement: Inositol and alpha-lactalbumin

Interventions

Inositol and alpha-lactalbuminDIETARY_SUPPLEMENT

The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)

Experimental

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • triglycerides levels ≥ 150 mg/dL
  • HDL ≤ 40 mg/dL
  • Fasting glycemia \> 100 mg/dL \<126 mg/dl
  • Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg
  • Hip circumference \> 102 cm in men or 88 cm in women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Medicina Interna e Nefrologia P.O. AQ

L’Aquila, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

InositolLactalbumin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesAlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary Proteins

Study Officials

  • Davide Grassi, MD

    UOC Medicina Interna e Nefrologia P.O. AQ

    PRINCIPAL INVESTIGATOR

  • Claudio Ferri, MD

    UOC Medicina Interna e Nefrologia P.O. AQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 19, 2023

Study Start

December 23, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-02

Locations

IT(1)