Exercise for Better Bones - Day or Night?

NCT05612412 | Terminated

• 1 other identifier: GFHNRC154
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Change in serum C-terminal telopeptide of type 1 collagen (CTX)

  Test the differences in morning peak serum CTX following one bout of exercise per day for 10 days over a two-week period in either the early morning or the evening.

  Day 1, Day 15

Study Arms (2)

Morning Exercise

EXPERIMENTAL

Morning exercise session

Other: Morning Exercise

Evening Exercise

EXPERIMENTAL

Evening exercise session

Other: Evening Exercise

Interventions

Morning Exercise OTHER

Standardized treadmill exercise session starting at approximately 0700

Morning Exercise

Evening Exercise OTHER

Standardized treadmill exercise session starting at approximately 1800

Evening Exercise

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women within 1-10 yr after menopause
• BMI 18.5-29.9 kg/m2
• Healthy as determined by a screening physical examination and blood chemistry related to thyroid, liver, kidney, and lipid profile within normal range
• No osteoporosis as determined by dual energy x-ray absorptiometry (DEXA) scan at femoral neck or total spinal region
• No 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 worker
• No 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 study
• Willing 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 study
• Able and willing to perform moderate intensity exercise without contraindications as determined by the Physical Activity Readiness Questionnaire
• Willing 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 period

You may not qualify if:

• Hypertension with resting blood pressure higher than systolic 140 and diastolic 90 mmHg
• Within 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 diet
• Any 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 supplement
• Diabetes 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 weeks
• Repeated non-compliance with completing prescribed exercise sessions
• Within past 6 weeks, used tanning booths or traveled to location with a tropic climate
• Use of antibiotics (Amoxicillin, doxycycline, etc.), nonsteroidal anti-inflammatory drugs (aspirin, Celebrex, etc.), or probiotics (Lactobacillus, Bifidobacterium) within the past 6 weeks
• Irritable bowel syndrome, inflammatory bowel disease, or not having a bowel movement three days or longer

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Cao, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: October 5, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)