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Completed

NCT Number: NCT04293003

Metabolic Effects of Morning 16/8 Fasting

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting

Other

6-hour fasting

Low carbohydrate

Other

Consumption of a zero-carbohydrate breakfast

Mediterranean

Other

Consumption of a Mediterranean-type breakfast

Primary outcomes

  1. Mobilisation of adipose tissue

    Time frame: 6 hours

    Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration

Secondary outcomes

  1. Mobilisation of gut peptides

    Time frame: 6 hours

    AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration

  2. Degree of appetite suppression

    Time frame: 6 hours

    Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite

  3. Degree of satiety induction

    Time frame: 6 hours

    Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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