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Metabolic responses to night-time eating: a randomised control trial in men with high fasting lipids

Metabolic responses to night-time eating: a randomised control trial in men with high fasting lipids

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001115224
Enrollment
16
Registered
2018-07-05
Start date
2015-09-15
Completion date
2016-04-13
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People who work out of synchronisation with their body clock e.g shift workers face higher rates of chronic diseases such as type 2 diabetes and cardiovascular disease. Eating at night time may contribute to this increased risk by forcing the body to break down and process food at a time usually associated with sleeping. Consuming the same meal at night time compared to the morning is associated with glucose intolerance, insulin resistance and changes in the expression of circadian genes. We hypothesise that altering the type of food consumed at night time may help modify these metabolic risks. In this study we aim to investigate the impact of two isocaloric meals differing in macronutrient composition on glucose and lipid homeostasis and expression of circadian genes in men with high fasting lipids kept awake overnight.

Interventions

Participants are required to undertake 2 overnight assessments (midnight to 6am) at the Be Active Sleep eat Facility BASE) at Monash University, Notting Hill. Prior to the first assessment participants are screened to ensure they meet eligibility criteria, anthropometric measurements are taken (height, weight and body composition), blood pressure and if deemed eligible asked to keep a 7 day food diary, sleep diary and wear an activity monitor for the same 7 day period prior to the first asses

Participants are required to undertake 2 overnight assessments (midnight to 6am) at the Be Active Sleep eat Facility BASE) at Monash University, Notting Hill. Prior to the first assessment participants are screened to ensure they meet eligibility criteria, anthropometric measurements are taken (height, weight and body composition), blood pressure and if deemed eligible asked to keep a 7 day food diary, sleep diary and wear an activity monitor for the same 7 day period prior to the first assessment. Participants are also required to complete a Medical and lifestyle history questionnaire to assess eligibility, Pittsburg Sleep Quality Index (PSQ1) to assess sleep habits over the last month and Morningness-Eveningness Questionnaire (MEQ) to assess whether the participants circadian rhythm produces peak alertness in the morning, in the evening, or in between. At 1200h and 1800h on the assessment days, subjects will be required to consume control meals and snacks for lunch and dinner (2636kJ, 29.4% protein, 49% carbohydrate, 32% fat and 1,288kJ, 14% protein, 66% carbohydrates and 15% fat, respectively). All control meals and snacks are to be consumed within 15 minutes. Subjects will then refrain from eating or drinking anything else (except for water) until they come into the BASE Facility for the night-time assessment. Upon arrival at the BASE facility at 23:00 for the assessment visits anthropometric (height, weight and body composition) measurements and blood pressure are recorded. The researchers will also check verbally that the control meals/snacks were consumed. An intravenous canula will then be inserted by an experienced nurse or phlebotomist 45 minutes before the start of the trial. One baseline blood sample will be taken at baseline ( time 0 minutes), followed by provision of a healthy meal (low glycaemic index meal) at 00:00 hrs (midnight) which participants will be asked to consume within 15 minutes. The test meal is a homemade vegetarian pasta dish (2.7 MJ, with 47% energy from carbohydrate (8% total sugars), 40% energy from fat (7% saturates) and 11% energy from protein). Blood sampling will be collected at 15,30,45,60,90.120,180.240,300, and 360 minutes for glucose, triglycerides and insulin. At hourly intervals, participants are asked about their subjective appetite by completing VAS scales on hunger and fullness, are asked to select from a picture of a vending machine what food they most feel like at that particular time point and to complete a Karolinska sleep scale (KSS) which is a measure of situational sleepiness. Blood samples for RNA extraction are being collected at 0, 120 and 240 minutes. The washout period between overnight assessment 1 and assessment 2 is a minimum of 7 days.

Sponsors

A/Prof Maxine Bonham
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Males, aged between 18 and 50 years, sedentary (rated as low/moderate physical activity on the short form International Physical Activity Questionnaire) , overweight (Body Mass Index (BMI) >= 25 kg/m2), with high fasting TAGs > 1..7 mmol/L who currently maintain a regular sleep-wake cycle.

Exclusion criteria

Participants who engage in shift work, smoke, currently taking any lipid lowering, anti-hypertensive, anti-depressive or thyroid deficiency medications, fasting glucose > 6 mmol/L, irregular meal patterns or consume excessive alcohol (>4 standard drinks per day).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026