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NCT05612412
Exercise for Better Bones - Day or Night?
Conditions: Overweight
Sex: Female
Ages: 45 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 25
Sponsor: USDA Grand Forks Human Nutrition Research Center
Location: United States
Summary
The purpose of this study is to find out if moderate exercise at different time during the day (early morning vs early evening) affects biomarker CTX of bone health in normal to overweight postmenopausal women.
Eligibility Criteria
Inclusion Criteria:Postmenopausal women within 1-10 yr after menopauseBMI 18.5-29.9 kg/m2Healthy as determined by a screening physical examination and blood chemistry related to thyroid, liver, kidney, and lipid profile within normal rangeNo osteoporosis as determined by dual energy x-ray absorptiometry (DEXA) scan at femoral neck or total spinal regionNo regular exercise for more than 30 minutes a day on more than 2 days a week and no physically active employment, such as maintenance and repair or delivery workerNo regular use of medications known to interfere with calcium and bone metabolism from 6 weeks prior to the study to the end of study such as medications for heartburn, reflux, H2 blockers, diuretics, etc. such as antacids, Maalox, Pepcid AC, Nexium, Diuril, etc.Weight stable (within 5 lbs change) for at least 3 months prior to the start of the studyWilling to maintain usual lifestyle and activities including the same wake-sleep schedule (go to sleep between 10:00 p.m. and midnight with an average 6-8 hours of sleep time)Refrain from the use of alcohol and nicotine (for example, cigarettes, cigars, and e-cigarettes) for the length of the studyAble and willing to perform moderate intensity exercise without contraindications as determined by the Physical Activity Readiness QuestionnaireWilling and able to stop any nutritional supplements including vitamin D supplements and calcium-containing medications (for instance, calcium-carbonate antacids)Willing not to use tanning booths during the study or not to travel to locations with a tropical climate two weeks prior to the study or during the washout periodExclusion Criteria:Hypertension with resting blood pressure higher than systolic 140 and diastolic 90 mmHgWithin past 6 weeks, had nutrition supplements or medications known to affect calcium metabolism and appetite such as Antacids, Megace, antacids, heartburn, reflux, H2 blockers, diuretics, etc.Allergy to any food ingredients used in the provided dietAny disorders affecting nutrient absorption or metabolism, such as cystic fibrosis, lactose intolerance, celiac disease, etc.Any sleep disorders such as sleep apnea or regular use of an over-the-counter melatonin supplementDiabetes or taking medications known to affect bone such as Actos, Avandia, Invokana, etc.Engaged in moderate to vigorous exercise or regular exercise for more than 30 minutes/day on more than 2 days/week within past 6 weeksRepeated non-compliance with completing prescribed exercise sessionsWithin past 6 weeks, used tanning booths or traveled to location with a tropic climateUse of antibiotics (Amoxicillin, doxycycline, etc.), nonsteroidal anti-inflammatory drugs (aspirin, Celebrex, etc.), or probiotics (Lactobacillus, Bifidobacterium) within the past 6 weeksIrritable bowel syndrome, inflammatory bowel disease, or not having a bowel movement three days or longer
Source: ClinicalTrials.gov (NCT05612412). StuddyBuddy aggregates publicly available trial information.