Clinical trial NCT03447600: Diet-Induced Variability in Appetite (DIVA)
Official title: The Impact of Weight Loss Through Alternate Day Fasting on Homeostatic and Hedonic Appetite Control and Eating Behaviour: a Proof of Concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2018-02-27
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female participants aged between 18 and 55 years at the time of signing informed consent
* BMI of 25.0 - 34.9 kg/m2

Exclusion Criteria:

* Significant health problems which in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
* Currently enrolled in a weight loss programme or following a specific diet plan.
* History of eating disorders including binge eating.
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known food allergies or food intolerance
* Smokers and those who have recently ceased smoking (\< 6 months)
* BMI \< 24.9 kg/m2 or \> 35 kg/m2
* Volunteers having lost significant amount of weight in the previous 6 months (± 4kg)
* Volunteers who exercise \> 3 days per week or have significantly changed their physical activity patterns in the past 6 months or who intend to change them during the study
* Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
* Participants who work in appetite or feeding related areas.
* Participants who do shift work

Primary outcomes:
measure: Change in energy intake from ad libitum lunch
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
Secondary outcomes:
measure: Change in Visual Analogue Scale (VAS) ratings of appetite
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in Control of Eating Questionnaire (CoEQ) scale scores
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in explicit liking of food from Leeds Food Preference Questionnaire
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in explicit wanting of food from Leeds Food Preference Questionnaire scores
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in relative preference of food from Leeds Food Preference Questionnaire scores
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in implicit wanting of food from Leeds Food Preference Questionnaire scores
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in VAS rating of palatability post lunch
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in fat mass
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in fat free mass
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in resting metabolic rate
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
measure: Change in free-living physical activity
timeFrame: week 0, week 3 and at study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Kristine Beaulieu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Graham Finlayson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaulieu K, Casanova N, Oustric P, Turicchi J, Gibbons C, Hopkins M, Varady K, Blundell J, Finlayson G. Matched Weight Loss Through Intermittent or Continuous Energy Restriction Does Not Lead To Compensatory Increases in Appetite and Eating Behavior in a Randomized Controlled Trial in Women with Overweight and Obesity. J Nutr. 2020 Mar 1;150(3):623-633. doi: 10.1093/jn/nxz296.