Diet-Induced Variability in Appetite (DIVA)

University of Leeds

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Alternate Day Fasting; Behavioral: Continuous dietary restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT03447600

LDS-DIVA-2017

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Alternate day fasting

Experimental group

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.

Treatment:

Behavioral: Alternate Day Fasting

Continuous caloric restriction

Active Comparator group

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.

Treatment:

Behavioral: Continuous dietary restriction