Metabolic Effects of Morning 16/8 Fasting

NCT ID: NCT04293003

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fasting

6-hour morning fasting

Group Type EXPERIMENTAL

fasting

Intervention Type OTHER

6-hour fasting

Low carbohydrate

Consumption of a zero-carbohydrate breakfast

Group Type EXPERIMENTAL

Low carbohydrate

Intervention Type OTHER

Consumption of a zero-carbohydrate breakfast

Mediterranean

Consumption of a Mediterranean breakfast

Group Type EXPERIMENTAL

Mediterranean

Intervention Type OTHER

Consumption of a Mediterranean-type breakfast

Interventions

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fasting

6-hour fasting

Intervention Type OTHER

Low carbohydrate

Consumption of a zero-carbohydrate breakfast

Intervention Type OTHER

Mediterranean

Consumption of a Mediterranean-type breakfast

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Alexandros Kokkinos

Associate Professor in Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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39/12-02-2019

Identifier Type: -

Identifier Source: org_study_id

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