NCT02635139

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

December 13, 2015

Last Update Submit

April 22, 2017

Conditions

Healthy

Keywords

meal skippingisocaloric dietmacronutrient oxidationglucose homeostasisarterial stiffness

Outcome Measures

Primary Outcomes (1)

  • Regulation of glucose metabolism (substrate oxidation and insulin sensitivity)

    1 day

Secondary Outcomes (2)

  • Actigraphy-assessed sleep quality

    1 day

  • cardio vascular risk (lipid profile, arterial stiffness, autonomic function)

    1 day

Study Arms (2)

Breakfast Skipping

EXPERIMENTAL

Effect of breakfast skipping on metabolism

Behavioral: Breakfast skipping

Dinner Skipping

EXPERIMENTAL

Effect of dinner skipping on metabolism

Behavioral: Dinner skipping

Interventions

Breakfast skippingBEHAVIORAL

18h fasting period in the morning

Breakfast Skipping
Dinner skippingBEHAVIORAL

18h fasting period in the evening

Dinner Skipping

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • not obese (BMI\<30)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

Location

Related Publications (1)

  • Nas A, Mirza N, Hagele F, Kahlhofer J, Keller J, Rising R, Kufer TA, Bosy-Westphal A. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr. 2017 Jun;105(6):1351-1361. doi: 10.3945/ajcn.116.151332. Epub 2017 May 10.

    PMID: 28490511DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Officials

  • Anja Bosy-Westphal, Prof PhD

    University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 18, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)