Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions

April 22, 2017 updated by: University of Hohenheim
Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping) on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch, dinner) serves as a control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of the study is 7 days including 3 days with controlled diet and 4 days (including 5 nights) in a metabolic chamber at the Institute of Nutritional Medicine at the University of Hohenheim.

The study phase in the metabolic chamber consists of (i) 1 day with 3 meals/day = baseline day, (ii) 1 day with breakfast skipping, (iii) 1 day with dinner skipping, (iv) 1 washout day where the subjects leave the chamber between 7 a.m. until 7 p.m..

Beginning on the 3rd study day macronutrient and energy intake as well as the fasting periods are kept constant. To achieve comparable conditions the washout day is setted before the baseline day.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70599
        • Institute of Nutritional Medicine, University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • not obese (BMI<30)

Exclusion Criteria:

  • food allergy
  • smoking
  • alternative nutrition habits
  • chronic disease
  • regular medication intake
  • claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breakfast Skipping
Effect of breakfast skipping on metabolism
Behavioral: Breakfast skipping
18h fasting period in the morning
Experimental: Dinner Skipping
Effect of dinner skipping on metabolism
Behavioral: Dinner skipping
18h fasting period in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Regulation of glucose metabolism (substrate oxidation and insulin sensitivity)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Actigraphy-assessed sleep quality
Time Frame: 1 day
1 day
cardio vascular risk (lipid profile, arterial stiffness, autonomic function)
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Investigators

  • Principal Investigator: Anja Bosy-Westphal, Prof PhD, University of Hohenheim, Stuttgart, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MealSkipping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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