Extended daily fasting (omission of breakfast) and regulation of energy balance

Not Applicable

Completed

• Conditions: Diet/inactivity/obesity-related diabetes and associated cardiovascular disease; Obesity-related diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN31521726
• Lead Sponsor: niversity of Bath (UK)

Brief Summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21740575 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24898233 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26864365 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29378040 2019 substudy results in https://www.ncbi.nlm.nih.gov/pubmed/30925197 (added 12/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-03
• Study Completion: 2013-04-14
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Participants may be male or female (females may or may not be taking oral contraceptives but must maintain a record of menstrual cycle phase or contraceptive use prior to entry into the study)
2. Those within the specified age range (20 - 60 years)
3. Individuals with a body mass index between 20 - 24 kg/m2 or above 30 kg/m2
4. Able and willing to safely comply with all study procedures
5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study

Exclusion Criteria

1. Women who are known to be pregnant or who are intending to become pregnant over the course of the study
2. Women who are breast feeding
3. Participation in another clinical trial
4. Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment
5. Any other condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias into the experiment
6. Individuals with any known bleeding disorder
7. Individuals currently taking any medication known to act as an anticoagulant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Alterations in energy balance between treatments (i.e. the culmination of resting metabolic rate, diet-induced thermogenesis and physical activity energy expenditure relative to dietary energy intake).<br><br> All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Both the mechanistic data explaining how the intervention may have impacted on energy balance (i.e. appetite regulatory hormones, metabolic regulatory hormones and associated expression of key genes) and also the whole-body endpoints indicative of altered health status with each treatment (i.e. adiposity, glycaemic control and chronic lowgrade<br> inflammation).<br><br> All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II.<br>