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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine Beaulieu, PhD | University of Leeds | Principal Investigator |
| Graham Finlayson, PhD | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leeds | Leeds | West Yorkshire | LS2 9JT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31825067 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. |
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| week 0, week 3 and at study completion, an average of 12 weeks |
| 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. | week 0, week 3 and at study completion, an average of 12 weeks |
| 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. | 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 | 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. | 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 | 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. | week 0, week 3 and at study completion, an average of 12 weeks |
| 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. | week 0, week 3 and at study completion, an average of 12 weeks |
| Change in VAS rating of palatability post lunch | Change in ratings of pleasantness, desire to eat more and palatability after the lunch test meal | week 0, week 3 and at study completion, an average of 12 weeks |
| Change in fat mass | Change in fat mass from iDXA/BodPod | week 0, week 3 and at study completion, an average of 12 weeks |
| Change in fat free mass | Change in fat free mass from iDXA/BodPod | week 0, week 3 and at study completion, an average of 12 weeks |
| Change in resting metabolic rate | Change in resting metabolic rate from indirect calorimetry | week 0, week 3 and at study completion, an average of 12 weeks |
| Change in free-living physical activity | Change in 7-day free-living physical activity from SenseWear Armband | week 0, week 3 and at study completion, an average of 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |