Evans Biomedical Research Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT04858932
Reduction in appetite and/or food intake among older individuals is referred to as anorexia of aging (AOA, also known as Geriatric Anorexia). AOA is linked with myriad comorbidities associated with aging, contributes significantly to adverse health consequences in old age, and has been used as a predictor of morbidity and mortality. The overall aim of this study is to assess the feasibility and burden of the proposed in-laboratory and out-of-laboratory assessments to study Geriatric Anorexia. This will be accomplished with the use of questionnaires as well as devices that evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale.
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Notify Me65 year–85 year
All sexes
Observational
Boston, Massachusetts, 02118, United States
This is a study to evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. Subjects, age 65 to 85 years will be recruited.
The proposed study will consist of an initial (in-clinic) intake visit on Day 1 where the subject will be screened and enrolled in the study after signing an informed consent document, followed by an at-home phase where the subject will wear a watch like device on one wrist. After training, the subject will return for their Day 8 in-clinic visit, where the subject will repeat some intake assessments and activities, as well as some additional standing and walking activities. The subject will then be asked to perform at-home activities and assessments with the use of a smart phone, digital food scale, smart body weight scale, and continuous glucose monitor, while continuing to wear the watch-like device and a movement measurement device around their waist (Days 8-21). A final in-clinic visit will take place on Day 21 for final assessments and device collection. A +/- 4 days will be allocated for the scheduling of all visits to accommodate subject's schedules and commitments. All in-laboratory activities will take place in the Laboratory for Human Neurobiology while in-home activities will be completed in the subject's home. The study procedures will be identical for all subjects for the three groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
[separated into the three groups based on the Fried Criteria: 0, 1-2, 3 or above]
Exclusion criteria
a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements
Other names: Freestyle Libre
a watch like wearable sensor
Other names: Geneactiv Watch
a scale to measure food weight
Other names: Renpho
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends
Other names: Renpho
Time frame: 21 days +/- 4 days
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction across the study period.
Time frame: 21 days +/- 4 days
A food scale will be used to track food consumed in grams (g) throughout the study. The total number of meals consumed per day and across study period.
Time frame: 21 days +/- 4 days
A body weight composition scale will be used to completion of daily weight measurement and track body weight in kilograms (kg) throughout the study.
Time frame: 21 days +/- 4 days
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction. This data will be compared to frailty phenotype per the Fried Frailty Scale and continuous glucose measurements.
Time frame: 21 days +/-4 days
A food scale will be used to track food consumed in grams (g) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
Time frame: 21 days +/-4 days
A body weight composition scale will be used to track body weight in kilograms (kg) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
Boston University
Other
Novel Digital Endpoints in Geriatric Anorexia
Acronym: GAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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