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

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ClinicalTrials.gov Identifier: NCT03447600
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Dr Graham Finlayson, University of Leeds

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).

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Alternate Day Fasting Behavioral: Continuous dietary restriction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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.
Behavioral: Alternate Day Fasting
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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. Change in fat free mass [ Time Frame: week 0, week 3 and at study completion, an average of 12 weeks ]
    Change in fat free mass from iDXA/BodPod

  10. 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

  11. Change in free-living physical activity [ Time Frame: week 0, week 3 and at study completion, an average of 12 weeks ]
    Change in 7-day free-living physical activity from SenseWear Armband



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447600


Locations
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United Kingdom
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Sponsors and Collaborators
University of Leeds
University of Illinois at Chicago
Investigators
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Principal Investigator: Kristine Beaulieu, PhD University of Leeds
Principal Investigator: Graham Finlayson, PhD University of Leeds
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Graham Finlayson, Chair in Psychobiology, University of Leeds
ClinicalTrials.gov Identifier: NCT03447600    
Other Study ID Numbers: LDS-DIVA-2017
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight