NCT05213988

Brief Summary

The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

6.4 years

First QC Date

December 6, 2021

Last Update Submit

January 25, 2022

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute 75g oral glucose tolerance test (OGTT)

    180 minutes

Study Arms (4)

Low-Carbohydrate/High-Protein Diet

EXPERIMENTAL
Dietary Supplement: Low-Carbohydrate/High-Protein diet

Fibrate

EXPERIMENTAL
Drug: Fibrates

Intermittent Fasting

EXPERIMENTAL
Dietary Supplement: Intermittent Fasting

Control

NO INTERVENTION

Interventions

Intermittent FastingDIETARY_SUPPLEMENT

Intermittent fasting meal pattern

Intermittent Fasting
FibratesDRUG

Bezafibrate 400 mg/day

Fibrate
Low-Carbohydrate/High-Protein dietDIETARY_SUPPLEMENT

Low-calorie, low-carbohydrate, high-protein diet

Low-Carbohydrate/High-Protein Diet

Eligibility Criteria

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

You may qualify if:

  • age 18-65 years
  • both males and females

You may not qualify if:

  • acute or chronic conditions influencing glucose and lipid metabolism
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Fibric AcidsDiet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsDiet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Andrea Natali, MD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 6, 2021

First Posted

January 28, 2022

Study Start

July 30, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)