NCT06483932

Brief Summary

Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 6, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

June 26, 2024

Last Update Submit

May 3, 2025

Conditions

HyperlipidemiasHypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration of triglycerides

    The plasma triglyceride concentration 12 hours after the subjects had fasted

    At baseline, the fourth week and the eighth week of study

  • Plasma concentration of high-density lipoprotein cholesterol (HDL-C)

    The plasma HDL-C concentration 12 hours after the subjects had fasted

    At baseline, the fourth week and the eighth week of study

Secondary Outcomes (7)

  • Body weight

    At baseline, the fourth week and the eighth week of study

  • Plasma Cholesterol

    At baseline, the fourth week and the eighth week of study

  • Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)

    At baseline and the eighth week of study

  • Plasma C-reactive protein

    At baseline and the eighth week of study

  • Plasma Insulin

    At baseline and the eighth week of study

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

A diet with a reduced calorie intake

Other: Low-calorie diet

Barberry

EXPERIMENTAL

A diet with a reduced calorie intake, coupled with the consumption of barberry

Other: Dried barberryOther: Low-calorie diet

Interventions

Dried barberryOTHER

Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.

Also known as: Berberis vulgaris
Barberry
Low-calorie dietOTHER

Diet with 500 kcal subtracted from the daily energy requirement

BarberryControl

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting serum triglycerides 150-499 mg/dL,
  • Body mass index 25-40 kg/m2
  • Age range 18-75 years

You may not qualify if:

  • Regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements
  • Regular consumption of flax seed or chia seed
  • Treatment with glucocorticoids
  • End-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshty Unversity Hospital

Kāshān, Isfahan, Iran

Location

MeSH Terms

Conditions

HyperlipidemiasHypertriglyceridemia

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Javad Nasrollahzadeh, Ph.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

September 9, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

May 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)