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Completed

NCT Number: NCT03447600

Diet-Induced Variability in Appetite (DIVA)

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).

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternate Day Fasting

Behavioral

25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.

Continuous dietary restriction

Behavioral

25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • University of Illinois at Chicago

Registry information

Official study 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

Acronym: DIVA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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