Metabolic Effects of Morning 16/8 Fasting

March 17, 2020 updated by: Alexandros Kokkinos, National and Kapodistrian University of Athens

Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.

At zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.

Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527
        • Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasting
6-hour morning fasting
Other: fasting
6-hour fasting
Experimental: Low carbohydrate
Consumption of a zero-carbohydrate breakfast
Other: Low carbohydrate
Consumption of a zero-carbohydrate breakfast
Experimental: Mediterranean
Consumption of a Mediterranean breakfast
Other: Mediterranean
Consumption of a Mediterranean-type breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobilisation of adipose tissue
Time Frame: 6 hours
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobilisation of gut peptides
Time Frame: 6 hours
AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration
6 hours
Degree of appetite suppression
Time Frame: 6 hours
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite
6 hours
Degree of satiety induction
Time Frame: 6 hours
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39/12-02-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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