Metabolic Effects of Morning 16/8 Fasting

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293003
• Other study ID #: 39/12-02-2019
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• fasting
6-hour fasting
• Low carbohydrate
Consumption of a zero-carbohydrate breakfast
• Mediterranean
Consumption of a Mediterranean-type breakfast

Locations

Country	Name	City	State
Greece	Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobilisation of adipose tissue	Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration	6 hours
Secondary	Mobilisation of gut peptides	AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration	6 hours
Secondary	Degree of appetite suppression	Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite	6 hours
Secondary	Degree of satiety induction	Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety	6 hours