Metabolic Effects of Morning 16/8 Fasting

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT04293003

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Other: fasting Other: Low carbohydrate Other: Mediterranean	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 7, 2020

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Feb 29, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mobilisation of adipose tissue [6 hours]
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine	Athens		Greece	11527

Sponsors and Collaborators

National and Kapodistrian University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandros Kokkinos, Associate Professor in Internal Medicine, National and Kapodistrian University of Athens

ClinicalTrials.gov Identifier:

NCT04293003

Other Study ID Numbers:

39/12-02-2019

First Posted:

Mar 3, 2020

Last Update Posted:

Mar 19, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Mar 19, 2020