Metabolic Effects of Morning 16/8 Fasting | NCT04293003

Studies
Metabolic Effects of Morning 16/8 Fasting

NCT04293003

Sponsor

National and Kapodistrian University of Athens

Status

Completed

Last Update Posted

Mar 19, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Overweight and Obesity

Interventions

fasting
Low carbohydrate
Mediterranean

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2020Actual

Primary Completion Date

Feb 29, 2020Actual

Completion Date

Feb 29, 2020Actual

First Submitted Date

Mar 1, 2020

First Submission Date that Met QC Criteria

Mar 2, 2020

First Posted Date

Mar 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2020

Last Update Posted Date

Mar 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

National and Kapodistrian University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
fasting	Other	6-hour fasting	Fasting
Low carbohydrate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine		Athens		11527	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C407088	Angptl4 protein, mouse

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided