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Metabolic Effects of Morning 16/8 Fasting

N

National and Kapodistrian University of Athens

Status

Completed

Conditions

Overweight and Obesity

Treatments

Other: fasting
Other: Mediterranean
Other: Low carbohydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04293003
39/12-02-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 3 patient groups

Fasting
Experimental group
Description:
6-hour morning fasting
Treatment:
Other: fasting
Low carbohydrate
Experimental group
Description:
Consumption of a zero-carbohydrate breakfast
Treatment:
Other: Low carbohydrate
Mediterranean
Experimental group
Description:
Consumption of a Mediterranean breakfast
Treatment:
Other: Mediterranean

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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