- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447600
Diet-Induced Variability in Appetite (DIVA) (DIVA)
November 4, 2020 updated by: Dr Graham Finlayson, University of Leeds
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alternate day fasting
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.
|
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
|
Active Comparator: Continuous caloric restriction
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.
|
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in energy intake from ad libitum lunch
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
Measured changes in ad-libitum energy intake following consumption of formulated test meal in comparison to control
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analogue Scale (VAS) ratings of appetite
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Change in Control of Eating Questionnaire (CoEQ) scale scores
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Change in explicit liking of food from Leeds Food Preference Questionnaire
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
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
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
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
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
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
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
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.
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Change in VAS rating of palatability post lunch
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
Change in ratings of pleasantness, desire to eat more and palatability after the lunch test meal
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week 0, week 3 and at study completion, an average of 12 weeks
|
Change in fat mass
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
Change in fat mass from iDXA/BodPod
|
week 0, week 3 and at study completion, an average of 12 weeks
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Change in fat free mass
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
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Change in fat free mass from iDXA/BodPod
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Change in resting metabolic rate
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
|
Change in resting metabolic rate from indirect calorimetry
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week 0, week 3 and at study completion, an average of 12 weeks
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Change in free-living physical activity
Time Frame: week 0, week 3 and at study completion, an average of 12 weeks
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Change in 7-day free-living physical activity from SenseWear Armband
|
week 0, week 3 and at study completion, an average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Graham Finlayson, PhD, University of Leeds
- Principal Investigator: Kristine Beaulieu, PhD, University of Leeds
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
December 12, 2018
Study Completion (Actual)
December 12, 2018
Study Registration Dates
First Submitted
February 9, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LDS-DIVA-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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