Completed
NCT Number: NCT02696772
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake
Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week. However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined. This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.
Completed
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- non-smoker, not currently dieting, weight stable for >6 months (self-reported), no known history of cardiovascular or renal disease.
Exclusion criteria
- food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (>4 units/day), intensive training schedule (>10 h/week)
Treatment and study plan
Primary outcomes
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Ad-libitum energy intake
Time frame: 48 hours
Measured at laboratory-based meals and weight food records
-
Subjective appetite
Time frame: 48 hours
Measured using visual analogue scales
-
Plasma acylated Ghrelin
Time frame: 24 hours
Measured using ELISA from venous blood samples
-
Plasma active glugagon-like peptide 1
Time frame: 24 hours
Measured using ELISA from venous blood samples
Secondary outcomes
-
Plasma insulin
Time frame: 24 hours
Measured using ELISA from venous blood samples
-
Plasma glucose
Time frame: 24 hours
Measured using colorimetric assay from venous blood samples
-
Plasma Non-esterified Fatty acids
Time frame: 24 hours
Measured using colorimetric from venous blood samples
-
Energy expenditure
Time frame: 24 hours
Measured under resting conditions using indirect calorimetry
-
Fat oxidation
Time frame: 24 hours
Measured under resting conditions using indirect calorimetry
-
carbohydrate oxidation
Time frame: 24 hors
Measured under resting conditions using indirect calorimetry
Sponsors and collaborators
Lead sponsor
Loughborough University
Other
Collaborators
- National Institute for Health Research, United Kingdom
Registry information
Official study title
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake in Lean Males and Females
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Mar 2, 2016
- Registry last updated
- Mar 3, 2016
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.