NCT04293003

Brief Summary

A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 1, 2020

Last Update Submit

March 17, 2020

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Mobilisation of adipose tissue

    Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration

    6 hours

Secondary Outcomes (3)

  • Mobilisation of gut peptides

    6 hours

  • Degree of appetite suppression

    6 hours

  • Degree of satiety induction

    6 hours

Study Arms (3)

Fasting

EXPERIMENTAL

6-hour morning fasting

Other: fasting

Low carbohydrate

EXPERIMENTAL

Consumption of a zero-carbohydrate breakfast

Other: Low carbohydrate

Mediterranean

EXPERIMENTAL

Consumption of a Mediterranean breakfast

Other: Mediterranean

Interventions

fastingOTHER

6-hour fasting

Fasting
Low carbohydrateOTHER

Consumption of a zero-carbohydrate breakfast

Low carbohydrate
MediterraneanOTHER

Consumption of a Mediterranean-type breakfast

Mediterranean

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-25 kg/m2
  • Willfulness to participate

You may not qualify if:

  • Overweight or obesity (BMI\>25 kg/m2)
  • Type 1 or 2 diabetes mellitus
  • Uncontrolled thyroid disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, 11527, Greece

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 3, 2020

Study Start

January 7, 2020

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)