An interventional study of Alternate Day Fasting and Continuous dietary restriction in Overweight and Obesity, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by University of Leeds · Not applicable, Interventional, and Basic science
The aim of this study is to test the hypothesis that dietary weight loss (WL) through alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing following WL compared to standard daily calorie restriction (CR).
This is a proof of concept randomized controlled trial in which overweight/obese females will be randomised to a dietary weight loss intervention (ADF or CR) to achieve ≥5% WL. Behavioural measures of appetite control including ad libitum intake after a fixed meal, body composition, resting metabolic rate, measured physical activity and daily energy expenditure, sleep quality, hedonic food reward and eating behaviour traits will be assessed before, during and after the WL intervention in those who reach the target weight loss within 12 weeks. After weight loss phase, participants will be given standard healthy eating and physical activity advice for weight maintenance and body weight will be followed up after weight loss at 12 months.
Exclusion Criteria:
Participants randomised to Alternate Day Fasting weight loss intervention. One day fasting of 25% total energy requirements alternated with one day ad libitum intake until study completion at \>/=5% weight loss which is an average of 12 weeks.
Behavioral: Alternate Day Fasting
Participants randomised to continuous caloric restriction weight loss intervention. Every day intake of 75% total energy requirements until study completion at \>/=5% weight loss which is an average of 12 weeks.
Behavioral: Continuous dietary restriction
25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.
25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.
Change in energy intake from ad libitum lunch
Measured changes in ad-libitum energy intake following consumption of formulated test meal in comparison to control
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in Visual Analogue Scale (VAS) ratings of appetite
Change in ratings of hunger, satiety, fullness and prospective food consumption before, after and between meals. Scale range is minimum 0 to maximum 100mm. A composite appetite score will be calculated from the average of scores on hunger, satiety, fullness and prospective food consumption scales. A higher score is considered a worse outcome.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in Control of Eating Questionnaire (CoEQ) scale scores
21-item scale; subscales are average of relevant items; subscales are computed for dimensions of Craving Control, Craving for Savoury, Craving for Sweet, Positive Mood; minimum subscale score = 0, maximum subscale score = 100; higher values are better outcome for Craving Control and Positive Mood subscales; lower values are better outcome for Craving for Sweet and Craving for Savoury subscales.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in explicit liking of food from Leeds Food Preference Questionnaire
Leeds Food Preference Questionnaire is a computer-based task with subscales scores for the 4 food categories high fat and sweet, high fat and non-sweet, low fat and sweet and low fat and non-sweet (minimum score = 0, maximum score = 100), Higher values for high fat food categories relative to low fat food categories considered worse outcome.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in explicit wanting of food from Leeds Food Preference Questionnaire scores
Leeds Food Preference Questionnaire is a computer-based task with subscales scores for the 4 food categories high fat and sweet, high fat and non-sweet, low fat and sweet and low fat and non-sweet (minimum score = 0, maximum score = 100), Higher values for high fat food categories relative to low fat food categories considered worse outcome.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in relative preference of food from Leeds Food Preference Questionnaire scores
Leeds Food Preference Questionnaire is a computer-based task with subscales scores for the 4 food categories high fat and sweet, high fat and non-sweet, low fat and sweet and low fat and non-sweet (minimum score = 0, maximum score = 48), Higher values for high fat food categories relative to low fat food categories considered worse outcome.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in implicit wanting of food from Leeds Food Preference Questionnaire scores
Leeds Food Preference Questionnaire is a computer-based task with subscales scores for the 4 food categories high fat and sweet, high fat and non-sweet, low fat and sweet and low fat and non-sweet (minimum score = -100, maximum score = 100), Higher values for high fat food categories relative to low fat food categories considered worse outcome.
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in VAS rating of palatability post lunch
Change in ratings of pleasantness, desire to eat more and palatability after the lunch test meal
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in fat mass
Change in fat mass from iDXA/BodPod
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in fat free mass
Change in fat free mass from iDXA/BodPod
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in resting metabolic rate
Change in resting metabolic rate from indirect calorimetry
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in free-living physical activity
Change in 7-day free-living physical activity from SenseWear Armband
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Plan to share: No
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University of Leeds