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Diet-Induced Variability in Appetite (DIVA) (DIVA)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Alternate Day Fasting
Continuous dietary restriction
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alternate day fasting

Continuous caloric restriction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Change in VAS rating of palatability post lunch
Change in ratings of pleasantness, desire to eat more and palatability after the lunch test meal
Change in fat mass
Change in fat mass from iDXA/BodPod
Change in fat free mass
Change in fat free mass from iDXA/BodPod
Change in resting metabolic rate
Change in resting metabolic rate from indirect calorimetry
Change in free-living physical activity
Change in 7-day free-living physical activity from SenseWear Armband

Full Information

First Posted
February 9, 2018
Last Updated
November 4, 2020
Sponsor
University of Leeds
Collaborators
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03447600
Brief Title
Diet-Induced Variability in Appetite (DIVA)
Acronym
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternate day fasting
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous caloric restriction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alternate Day Fasting
Intervention Description
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Continuous dietary restriction
Intervention Description
25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
Primary Outcome Measure Information:
Title
Change in energy intake from ad libitum lunch
Description
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
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Scale (VAS) ratings of appetite
Description
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
Title
Change in Control of Eating Questionnaire (CoEQ) scale scores
Description
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
Title
Change in explicit liking of food from Leeds Food Preference Questionnaire
Description
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
Title
Change in explicit wanting of food from Leeds Food Preference Questionnaire scores
Description
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
Title
Change in relative preference of food from Leeds Food Preference Questionnaire scores
Description
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
Title
Change in implicit wanting of food from Leeds Food Preference Questionnaire scores
Description
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
Title
Change in VAS rating of palatability post lunch
Description
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
Title
Change in fat mass
Description
Change in fat mass from iDXA/BodPod
Time Frame
week 0, week 3 and at study completion, an average of 12 weeks
Title
Change in fat free mass
Description
Change in fat free mass from iDXA/BodPod
Time Frame
week 0, week 3 and at study completion, an average of 12 weeks
Title
Change in resting metabolic rate
Description
Change in resting metabolic rate from indirect calorimetry
Time Frame
week 0, week 3 and at study completion, an average of 12 weeks
Title
Change in free-living physical activity
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Beaulieu, PhD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Finlayson, PhD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31825067
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.
Results Reference
derived

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Diet-Induced Variability in Appetite (DIVA)

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