None listed
Conditions
Brief summary
Sleep studies have shown that changes in sleep and wake-promoting neurochemicals until bedtime impact sleep onset and maintenance. The neurotransmitters involved in sleep onset include melatonin, serotonin, gamma-aminobutyric acid and adenosine. Diet, specifically fruit has been shown to impact the levels of these neurotransmitters. Based on our findings, a single evening consumption of dried green kiwifruit (including skin) mixed with water significantly improved subjective sleep quality measures and increased urinary concentrations of serotonin breakdown product compared to water alone. The primary aim of this study is to confirm whether dried kiwifruit significantly reduces sleep onset compared to control and determine if the metabolites responsible for sleep onset are responsible. The secondary aims are to determine whether there is cognitive benefit the following morning if sleep is improved with dried kiwifruit drink. A randomised controlled, crossover trial is planned. Participants will attend the Human Nutrition Unit in the evening and will be given a standardised meal with one of three interventions to consume for dinner. Interventions will be mixed with water and include whole freeze-dried green kiwifruit, a sugar control or a flavour control. Blood urine and saliva samples will be collected and mood, stress and physical activity questionnaires completed. At the end of the evening, participants will be allowed to go home. The following morning, participants will collect urine and saliva samples and complete sleep quality surveys and a mood survey. They will then come back to the unit undergo a cognitive test. After a washout period of approx. seven days, the next intervention will be consumed until all three interventions have been consumed.
Interventions
Screening visit Prospective participants will be provided with the study information sheet and invited to a Human Nutrition Research Unit (HNRU) screening session to sign the consent form and have height and weight measured, complete health questionnaires, and sleep quality questionnaires (PSQI, and ISI). Eligible participants will be enrolled. From this point on, participants will be asked to refrain from eating kiwifruit until the end of the study and maintain a sleep schedule. A case report form record (CRF) will be generated for all participants who have signed the consent form for the study, regardless of eligibility and/or continuing participation. Familiarisation Seven days before the first trial visits, participants will be invited for a familiarisation session. Participants will be asked to arrive at the HNRU between 6-8pm. The HNRU will be dimly lit to collect metabolites of interest. Once arrived, participants will be talked through exactly what would happen on a trial day with the lead researcher. They will be provided with an actigraphy watch to be used until the completion of the study and a survey booklet to be completed before the next trial visit. The survey booklet will contain a three-day food diary and a daily sleep diary. Participants will be told to activate the phase marker on the actigraphy watches when they are about to sleep and upon waking. No biomarker will be collected at his session and it is expected it will take Which will last approximately 1-2 hours. Once everything is complete, the participant will be escorted to on-site accommodation and asked to return the following morning fasted at an agreed time. Upon arriving in the morning, participants will be provided a standardised breakfast and asked to complete a cognitive test; this is used to ensure practice and learning effects are mitigated for subsequent trial visits. This morning visits will be no more than 2 hours. Intervention visits Two days before the scheduled trial visit, participants will be asked to refrain from consuming oranges, pineapples, bananas, mangos, papayas, plums, grapes, cherries, strawberries, tomatoes, capsicum, pistachios, plantains, mushrooms, chocolate, teas and coffee as these are known foods to contain and impact levels of serotonin and melatonin in urine (32-34). On the day of the trial, participants will attend HNRU between 5-6:30 pm. Participants will be asked to have their last meal five hours before the lab visit and only take water until the visit. On arrival, the participant will be asked whether they have consumed any of the restricted foods two days before or undergone exercise on this day. If the participant has consumed restricted items or exercised, the study visit will be rescheduled. If the participant has not, they will continue with the trial visit and follow the schedule below. Participants will be asked to complete a set of questionnaires (including abbreviated Profile of Mood States (POMS), International Physical Activity Questionnaire (IPAQ), Weekly Stress Inventory (WSI)) and provide a urine sample. A person trained in cannulation and venepunctures will insert a venous cannula in the arm vein of the participant to collect blood samples across multiple times points. At each blood sample, the participant's level of sleepiness will be rated according to the validated Stanford Sleepiness Scale (SSS). Approximately twenty minutes after the first blood sample, participants will be provided with a standardised evening meal [Man Size Spaghetti and Meatballs (McCain Foods), ~720 kcal], and the intervention to consume. The intervention will be in an opaque white bottle to mask what intervention the participant may be consuming. The dietary interventions will be given in random order. They will include (1) control (Flavour and colour) mixed with 200ml water, (2) control sugar (matched sugar, flavour, and colour) dissolved in 180ml water or (3) freeze-dried whole (flesh and skin) green kiwifruit (32g which is equivalent to two green kiwifruits) dissolved in 170 ml of water. Once the meal is finished, participants will be asked to sit and do light activities such as reading a book. They will also be asked not to use mobile phones or computers during their time in the lab. Six blood samples will be collected (~100mL each) beginning on arrival and 30, 60, 120, 180, 240 min post evening meal. The last blood sample will be collected at approximately 10-11 pm (differs for each participant) and the cannula will be removed after this. The participant will be asked to complete the POMS survey and provide a urine sample. They will then be provided with a urine sample collection container, saliva collection containers and survey booklet to be completed in their room the following morning. Participants will be escorted to on-site accommodation. Once settled, when the participant is ready for bed, they are asked to activate the phase marker on the actigraphy watch. Upon waking the following day, participants will be asked to activate the phase marker, collect the whole first-morning urine sample, collect four saliva samples (0, 30, 45, 60 min after waking) and complete the set of surveys. The validated surveys that will be completed in the morning are the SSS, Leeds Sleep Evaluation Questionnaire (LSEQ) and POMS. Participants will be asked to come into HNRU at the allocated time, fasted and with their urine, saliva samples and completed booklet 2-4 hours after waking. Upon arriving at the HNRU, participants will be provided with a standardised breakfast. The participant will be asked to complete a cognitive test as they did at the familiarisation session. Once they have completed this, the participant will be free to go. Participants will repeat the in-lab visit two more times separated by seven days until each intervention has been consumed.
Sponsors
Study design
Eligibility
Inclusion criteria
Healthy males Aged between 18-45 years of age Body mass index (BMI) (18.5-30kg/m2) Physically active but no more than 2 hours per day Poor sleepers, defined as having an ISI (Insomnia Severity Index) score of >8 (Ree, Pollitt, & Harvey, 2006) and the Pittsburgh Sleep Quality Index (PSQI) score >5 (Buysse, Reynolds III, Monk, Berman, & Kupfer, 1988)
Exclusion criteria
The intended participants will be healthy males who are poor sleepers as defined by a screening survey (PSQI and ISI), aged between 18-45years old, and have a body mass index between 18.5-30kg/m2. Exclusion criteria will include use of certain medications that affect digestion and sleep, excessive alcohol intake, smoking, history of gastrointestinal disorders, medical conditions related to digestive function and chronic sleep disorders, psychiatric conditions, antibiotic consumption (1 month prior), blood donation (3 months prior), on a strict weight loss diet, vegan/vegetarian, diagnosed with COVID-19, aversion to blood sampling or difficult veins, and allergies to dairy, eggs, cereals, soy and kiwifruit.