NCT05069298

Brief Summary

Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat. Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake. Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 29, 2021

Last Update Submit

June 22, 2023

Conditions

Overweight and ObesityHypercholesterolemiaHypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of total body weight loss

    Change in body weight from baseline to the end of study period (3 months).

    3 months

Secondary Outcomes (6)

  • Plasma total cholesterol

    3 months

  • Plasma low density level cholesterol (cLDL)

    3 months

  • Plasma triglycerides

    3 months

  • Body mass index (BMI)

    3 months

  • Body fat percentage

    3 months

  • +1 more secondary outcomes

Study Arms (2)

INTERVENTION

EXPERIMENTAL

Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal.

Dietary Supplement: Silibinin A

CONTROL

PLACEBO COMPARATOR

Similar treatment regimen, but with a placebo.

Dietary Supplement: Silibinin A

Interventions

Silibinin ADIETARY_SUPPLEMENT

The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

Also known as: Milk thistle derivative
CONTROLINTERVENTION

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 24,9
  • Voluntarily participate in the study

You may not qualify if:

  • significant cognitive impairment
  • psychiatric disorders
  • chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
  • chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
  • acute disease episodes during the study
  • subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing. Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Links

MeSH Terms

Conditions

OverweightObesityHypercholesterolemiaHypertriglyceridemia

Interventions

Silybin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

SilymarinFlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Juan José Hernández Morante, PhD

    Catholic University of Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main researcher at Eating-related disorders research unit

Study Record Dates

First Submitted

May 29, 2021

First Posted

October 6, 2021

Study Start

January 12, 2023

Primary Completion

December 1, 2023

Study Completion

December 21, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

ES(1)