The effect of a hops extract on hunger and appetite in healthy men during a 24 fast.

INTERVENTION: Subjects will consume, in randomized, double‐blind fashion (cross‐over design), gastric digestion resistant capsules (DRCaps, Capsugel) containing i) 500mg (2x250mg) super critical CO2 extract of hops flower (Amarasate), ii) 200mg (2x100mg) Amarasate, or iii) matching placebo (control). Each subject will receive half the total treatment twice during a given study day (at 10:00 and 14:00), and treatments i, ii, and iii will occur on separate occasions. Study visits will be separated by at least 7 days. During study laboratory visits, the lead researchers will be present to closely monitor adherence to study protocol. At 6pm on the evening prior to study day, participants will be instructed to not consume and food or drinks other than water, with compliance determined by participant self‐report. On each study day, subjects will being the laboratory based assessments at 10:00 hr (t=0 min) and will complete appetite‐related VAS and food cravings questionnaires throughout to study day. Immediately following the first questionnaire, subjects will ingest the first treatment capsules of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water, within 2 mins. VAS questionnaires will be collected 30‐min intervals from 10:00 (t=0 min) to 18:00h (t=480min) of the study day. Food craving questions will be asked at 10:00h, 12:00h, 14:00h, 16:00h and 18:00h. At 14:00h subjects will be giving the second treatment capsule (matched to the one given at 10:00h) of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water and to be consumed within 2 mins. VAS and food craving questionnaires continue as described above. At 18:00h, subjects will be allowed to leave the laboratory. CONDITION: Diet and Nutrition ‐ Obesity obesity; ; obesity PRIMARY OUTCOME: Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Fullness; ; [VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Hunger; ; ; [VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Satisfaction; ; ; ; [VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] SECONDARY OUTCOME: Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Thoughts of Food ; ; ; Assessments will be based on changes in macronutrient make‐up, energy density, classification of food type and total energy of foods thought of/desired. "Why" food is desired is will be assessed based on primary descriptor used for choice justification. [Measures will be taken through the 16h to 24h fasting period ever 120 mins. Specifically at 1000h (t=0), 1200h, 1400h, 1600h and 1800h (t=480)] Rebound energy intake, As assessed by comparing food diaries taken 3 days before the 24h fast day to food diary completed for the 24h post fast. [Food diaries will be taken for 3 days (72h) prior to the start of each 24h fast trial day and for 1 day (24h) after the completion of each of the 24h fast trial days. INCLUSION CRITERIA: Males Aged 18‐55 years BMI 20‐25kg/m2 Normal gross gastrointestinal tract anatomy, as ascertained by self‐report ; Note: This is a primary outcome.[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Fast‐Related Side effects.[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Current thought of compliance to Fast, [VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Difficulty in maintaining fast,[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Prospective thoughts of future compliance to a fast,[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Bloating[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Crap/Discomfort[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Energy ; Specifically, pre‐fast diaries will be started at 1800h 3 days prior to the commencement of the fast and finish 72 hours later at 1800h (0h of fast, t=‐960). Post‐fast diaries will be started immediately post‐fast at 1800h (t=480) and finish 24 hours later at 1800h the following day. ] Generally healthy, as ascertained by self‐report Regularly eat breakfast and lunch and dinner, as determined by self‐reporting. ; [VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Heart Burn[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Nausea[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Sickness[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Thirst[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Changes in subjective measures of possible side‐effects as determined by Visual Analogue Scale (VAS) for Vomiting[VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)] Food Cravings as determined by open ended questions: "What food are you thinking of right now?", and "If you could, what would you eat and why?"