Metabolic Effects of Morning 16/8 Fasting

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Mediterranean; Other: Low carbohydrate; Other: fasting

• Registration Number: NCT04293003
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study Start: 2020-01-07
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-03
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mediterranean	Mediterranean	Consumption of a Mediterranean breakfast
Low carbohydrate	Low carbohydrate	Consumption of a zero-carbohydrate breakfast
Fasting	fasting	6-hour morning fasting

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine; 🇬🇷 Athens, Greece