Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT03490825
This study aims to enhance circadian signals to improve cardiometabolic functions in older adults though meal timing interventions and melatonin supplements. Cardiometabolic disease (CMD) is prevalent among older adults, but despite vigorous research to prevent it, it remains on of the greatest public health challenges. Previous research has shown that extended overnight fasting and melatonin supplements may enhance circadian signals which in turn would enhance cardiometabolic function in older adults.
This study will place subjects in one of four intervention groups, 1) Meal timing + Melatonin, 2) Meal timing + Placebo, 3) Melatonin, or 4) Placebo in order test out the effects of meal timing and melatonin both separately and together and cardio metabolic functions. The study will explore the effects of these interventions in acute-based setting and extended-based settings. This will allow us to test out the hypotheses of the study that meal timing can improve amplitude of circadian signals and improve cardiometabolic functions and sleep quality as well as melatonin improving cardiometabolic function and sleep quality. Finally, we will determine if the the addition of melatonin will further enhance the effects of the meal timing intervention for improving cardiometabolic function and sleep.
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Notify Me55 year–75 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Melatonin (1mg) will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
Placebo will be administered daily during the intervention. The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the pills so the placebo (lactose/starch) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
Other names: Extended overnight fasting (EOF)
Subjects are instructed to maintain their habitual meal timing.
Other names: Non-extended overnight fasting (nEOF)
Time frame: 8 weeks
The matsuda index of whole body index sensitivity will be calculated to explore the effect of sleep and circadian rhythms on the relationship between EOF, melatonin, and CMD.
Time frame: 8 weeks
Defined as a ratio of sleep blood pressure to wake blood pressure less than 0.90.
Time frame: 8 weeks
The melatonin amplitude will be calculated to determine the effects of the interventions on sleep and CMD outcomes.
Northwestern University
Other
Enhancing Circadian Signal to Improve Cardiometabolic Function in Aging
Acronym: PPG6
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