Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women

NCT06901076 | Completed

• 1 other identifier: NST 01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 120 subjects in one center will be enrolled and will be divided into two treatment groups of 60 subjects each with 1:1 allocation ratio. Permuted block randomization will be used. Active treatment inlcude Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months; Control Intervention is Placebo.

Conditions

Perimenopausal Disorder; Impaired Glucose Tolerance; Impaired Fasting Glycemia

Outcome Measures

Primary Outcomes (1)

• Effect on cholesterol and glycemia

  The primary outcome is the comparison of two arms (Nisatol® supplement vs Placebo) for the effects on fasting plasma glucose and total cholesterol

  6 months

Secondary Outcomes (2)

• LDL and HDL-cholesterol

  6 months

• Glycemic status

  6 months

Study Arms (2)

Nisatol

EXPERIMENTAL

Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months

Dietary Supplement: Nisatol

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Nisatol DIETARY_SUPPLEMENT

Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months

Nisatol

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• perimenopausal women (irregular cycles up to intervals of more than 60 days)
• FPG values between 100 and 125 mg/dl and confirmation with oral glucose tolerance test (OGTT)
• TC values ≥ 200 mg/dl

You may not qualify if:

• neoplastic diseases
• liver diseases
• renal insufficiency
• diabetes mellitus

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale 1

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm randomized, placebo-controlled, double-blind, parallel-groups trial

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: March 12, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)