Overweight and ObesityDIVANCT03447600
Diet-Induced Variability in Appetite (DIVA)
A study testing Alternate Day Fasting and Continuous dietary restriction in people with Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Alternate Day Fasting and Continuous dietary restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged between 18 and 55 years at the time of signing informed consent
- BMI of 25.0 - 34.9 kg/m2
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
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
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).
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Alternate Day Fasting, Continuous dietary restriction
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Day FastingBehavioural
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
Continuous dietary restrictionBehavioural
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alternate day fasting | Experimental | 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. Receives: Behavioral: Alternate Day Fasting |
| Continuous caloric restriction | Active comparator | 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. Receives: Behavioral: Continuous dietary restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 0, week 3 and at study completion, an average of 12 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: week 0, week 3 and at study completion, an average of 12 weeks
Change in fat mass
Change in fat mass from iDXA/BodPod
Measured: 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
Measured: 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
Measured: 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
Measured: week 0, week 3 and at study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Mar 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Dr Graham Finlayson, University of Leeds
- Investigators
- Kristine Beaulieu, PhD, Principal investigator, University of LeedsGraham Finlayson, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447600
- Sponsor's protocol ID
- LDS-DIVA-2017
- Acronym
- DIVA
- Status last verified
- Nov 2020
- First submitted
- 9 Feb 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31825067
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03447600
- Acronym / sponsor ID
- DIVA / LDS-DIVA-2017
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternate day fasting | Experimental | Behavioral: Alternate Day FastingParticipants 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. |
| Continuous caloric restriction | Active comparator | Behavioral: Continuous dietary restrictionParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female participants aged between 18 and 55 years at the time of signing informed consent
- BMI of 25.0 - 34.9 kg/m2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Day Fasting25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks. | Behavioural | Alternate day fasting |
| Continuous dietary restriction25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks. | Behavioural | Continuous caloric restriction |
Primary outcome
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
11 secondary outcomes
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 Control of Eating Questionnaire (CoEQ) scale scores
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
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
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
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
Time frame: 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 fat mass
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Change in fat free mass
Time frame: 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 free-living physical activity
Time frame: week 0, week 3 and at study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 31825067Beaulieu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Beaulieu, PhD principal investigator
University of Leeds
Graham Finlayson, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Day Fasting and Continuous dietary restriction in people with Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in energy intake from ad libitum lunch (time frame: week 0, week 3 and at study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.