Diet-Induced Variability in Appetite (DIVA)

NCT03447600 | Completed

• 1 other identifier: LDS-DIVA-2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  week 0, week 3 and at study completion, an average of 12 weeks

• Change in Control of Eating Questionnaire (CoEQ) scale scores

  week 0, week 3 and at study completion, an average of 12 weeks

• Change in explicit liking of food from Leeds Food Preference Questionnaire

  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

  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

  week 0, week 3 and at study completion, an average of 12 weeks

Study Arms (2)

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.

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.

Behavioral: Continuous dietary restriction

Interventions

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.

Alternate day fasting

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.

Continuous caloric restriction

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged between 18 and 55 years at the time of signing informed consent
• BMI of 25.0 - 34.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31825067 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristine Beaulieu, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

• Graham Finlayson, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair in Psychobiology

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: March 1, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)