Back to resultsMetabolic Effects of Morning 16/8 Fasting
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
fasting
Low carbohydrate
Mediterranean
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity
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
Sites / Locations
- Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Fasting
Low carbohydrate
Mediterranean
Arm Description
6-hour morning fasting
Consumption of a zero-carbohydrate breakfast
Consumption of a Mediterranean breakfast
Outcomes
Primary Outcome Measures
Mobilisation of adipose tissue
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration
Secondary Outcome Measures
Mobilisation of gut peptides
AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration
Degree of appetite suppression
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite
Degree of satiety induction
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety
Full Information
NCT ID
NCT04293003
First Posted
March 1, 2020
Last Updated
March 17, 2020
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04293003
Brief Title
Metabolic Effects of Morning 16/8 Fasting
Official Title
Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasting
Arm Type
Experimental
Arm Description
6-hour morning fasting
Arm Title
Low carbohydrate
Arm Type
Experimental
Arm Description
Consumption of a zero-carbohydrate breakfast
Arm Title
Mediterranean
Arm Type
Experimental
Arm Description
Consumption of a Mediterranean breakfast
Intervention Type
Other
Intervention Name(s)
fasting
Intervention Description
6-hour fasting
Intervention Type
Other
Intervention Name(s)
Low carbohydrate
Intervention Description
Consumption of a zero-carbohydrate breakfast
Intervention Type
Other
Intervention Name(s)
Mediterranean
Intervention Description
Consumption of a Mediterranean-type breakfast
Primary Outcome Measure Information:
Title
Mobilisation of adipose tissue
Description
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Mobilisation of gut peptides
Description
AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration
Time Frame
6 hours
Title
Degree of appetite suppression
Description
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite
Time Frame
6 hours
Title
Degree of satiety induction
Description
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
City
Athens
ZIP/Postal Code
11527
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metabolic Effects of Morning 16/8 Fasting
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