Meal Timings, Appetite, Mood and Weight Loss in Individuals on a Commercial Intermittent Fasting Programme

Weight Loss Clinical Trial

— DASMA  

Official title:

Observational Study to Assess Associations Between Daily Meal Timings, Appetite, Mood and Weight Loss in Individuals Completing a Commercial Intermittent Fasting Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893772
• Other study ID #: DASMA_KCL
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although individuals following commercial intermittent fasting programmes consume meal replacement products during fasting days, further behavioural variables such as time of food consumption, sleep quality and duration, appetite and mood may significantly impact weight loss and intervention success. This project aims to assess behavioural patterns (dietary intake, sleep, meal timing, physical activity), mood and appetite on both fasting and non-fasting days and to investigate whether these are associated with weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those responding to adverts on the LighterLife Fast Challenge social media channels will be asked if they would like to participate

Exclusion Criteria:

• Those without access to a smart phone or laptop will not be eligible to take part in the study due to the need to report variables daily

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Dietary Supplement:
• Intermittent fasting
Three "fasting" days a week, whereby participants consume 600-800 kcal/day from 4 meal replacement products: breakfast, lunch, a snack and dinner. During the other 4 non-fasting "smart" days each week, participants are instructed to consume 2 x 300 kcal meals and 2 x 100 kcal snacks, from a selection of recipes, plus one meal of their own choosing.

Locations

Country	Name	City	State
United Kingdom	Department of Nutritional Sciences, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	LighterLife (UK) Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight in kg	Weighed at home	Change in body weight up to 12 weeks
Secondary	Sleep duration	Pittsburg Sleep Quality Index (PSQI) questionnaire	Before weight loss programme (day 0)
Secondary	Sleep quality	Pittsburg Sleep Quality Index (PSQI) questionnaire	Before weight loss programme (day 0)
Secondary	Physical activity	Simple Physical Activity Questionnaire (SIMPAQ)	Before weight loss programme (day 0)
Secondary	Meal timings	Meal timings questionnaire	Before weight loss programme (day 0)
Secondary	How hungry do you feel?	Visual Analogue Scales, scale of 0 (I am not hungry at all) -100 (I have never been more hungry)	Daily from day 1 up to 12 weeks
Secondary	How satisfied do you feel?	Visual Analogue Scales, scale of 0 (I am completely empty) -100 (I cannot eat another bite)	Daily from day 1 up to 12 weeks
Secondary	How full do you feel?	Visual Analogue Scales, scale of 0 (not at all) -100 (totally full)	Daily from day 1 up to 12 weeks
Secondary	How much do you think you can eat?	Visual Analogue Scales, scale of 0 (nothing at all) -100 (a lot)	Daily from day 1 up to 12 weeks
Secondary	Would you like to eat something sweet?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Secondary	Would you like to eat something salty?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Secondary	Would you like to eat something savoury?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Secondary	Would you like to eat something fatty?	Visual Analogue Scales, scale of 0 (yes very much) -100 (not at all)	Daily from day 1 up to 12 weeks
Secondary	Overall my mood is (very unpleasant to very pleasant)	Brief Mood Introspection Scale (BMIS), scale -10 to 10	Daily from day 1 up to 12 weeks
Secondary	Mindfulness - I was finding to difficult to stay focused on what I was doing	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Secondary	Mindfulness - I was doing something without paying attention	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Secondary	Mindfulness - I was preoccupied with the future or the past	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Secondary	Mindfulness - I was doing something automatically without being aware of what I was doing	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Secondary	Mindfulness - I was rushing through something without really being attentive to it.	Mindful Attention Awareness Scale (MASS), scale 0 (not at all) to 6 (very much)	Weekly from week 1 up to 12 weeks
Secondary	Height	Height in cm	Before weight loss programme (day 0)
Secondary	Dietary intake (macronutrients and energy)	24 h recall x 2	Before weight loss programme (day 0)
Secondary	Diet quality	24 h recall x 2	Before weight loss programme (day 0)
Secondary	Dietary intake (macronutrients and energy)	24 h recall x 4 (4 non-fasting days)	Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Secondary	Diet quality	24 h recall x 4 (4 non-fasting days)	Non-fasting days: Weeks 1, 2, 3, 4, 8 and 12
Secondary	Meal replacement product choice	Question: Which meal replacement products did you consume?	Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Secondary	Meal replacement product timings	Question: What time did you consume the meal replacement products?	Fasting days: Weeks 1, 2, 3, 4, 8 and 12
Secondary	Sleep duration	Question: How long did you sleep?	Daily from day 1 up to 12 weeks
Secondary	Sleep quality	Questions to rate quality of sleep	Daily from day 1 up to 12 weeks
Secondary	Physical activity	Question: Did you do any structured exercise today?	Daily from day 1 up to 12 weeks
Secondary	Alcohol use	AUDIT questionnaire	Before weight loss programme (day 0)