NCT04138160.

Study name	Effects of two weeks of twice‐weekly intermittent energy restriction on basal and postprandial metabolism
Methods	Randomised controlled trial
Participants	Ages Eligible for Study: 20 years to 35 years (adult) Sexes Eligible for Study: all Accepts Healthy volunteers: yes Inclusion Criteria Ages between 20 ‐ 35 years Healthy with a BMI between 20 and 27 kg·m‐2 Waist circumference < 94 cm for males and < 80 cm for females Ability to give informed consent
Interventions	Experimental: twice‐weekly intermittent energy restriction The twice‐weekly intermittent energy restriction (IER) of 70% restriction (~600 kcal) delivered for two non‐consecutive days/week and no restriction (so sufficient energy to meet the requirement of participants) on the other 5 days/week. Other: twice‐weekly Intermittent energy restriction Substantial (70%) energy restriction for 2 non‐consecutive days/week interspersed with normal energy intake (isoenergetic) on the remaining 5 days of the week. Other name: twice‐weekly IER Continuous energy restriction The continuous energy restriction (CER) of 20% restriction below the estimated requirement of participants (~1600 kcal) 7 days/week. Other: Continuous energy restriction 20% energy restriction each day relative to the energy requirement. Other name: CER
Outcomes	Primary Outcome Measures: Incremental area under the curve for insulin [ Time Frame: Over three hours from baseline ] Incremental area under the curve for serum insulin will be calculated using samples at 20 minute intervals between baseline and three hours. Secondary Outcome Measures: Incremental area under the curve for arterialised whole blood glucose [ Time Frame: Over four hours post baseline ] Incremental area under the curve for arterialised whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours. Incremental area under the curve for composite appetite score [ Time Frame: Over four hour from baseline ] Composite appetite score will be calculated using 100mm visual analogue score ratings of satiety, fullness, hunger and prospective food consumption collected very 20 minutes between baseline and four hours. Weight of consumption of a pasta meal three hours after baseline [ Time Frame: Three hours post baseline ] Weight of pasta consumed from a bowl refilled prior to being empty until participants feel comfortably full. Incremental area under the curve for free fatty acid [ Time Frame: Over three hours from baseline ] Incremental area under the curve for FFA will be calculated using samples at 20 minute intervals between baseline and three hours. Incremental area under the curve for TAG [ Time Frame: Over three hours from baseline ] Incremental area under the curve for TAG will be calculated using samples at 20 minute Continuous glucose monitoring [ Time Frame: Over last 6 days of intervention ] Average glucose of 6 days
Starting date	October 18, 2018
Contact information	Ian Macdonald, PhD University of Nottingham
Notes	NCT04138160