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TerminatedNCT05612412Updated Apr 11, 2025

Exercise for Better Bones - Day or Night?

An interventional study of Morning Exercise and Evening Exercise in Overweight, sponsored by USDA Grand Forks Human Nutrition Research Center. Terminated at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by USDA Grand Forks Human Nutrition Research Center · Not applicable, Interventional, and Other

Why this study was terminated
Slow recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

The overall objective of this study is to investigate whether the daily timing of exercise affects bone turnover markers in postmenopausal women. Results from this clinical trial will provide valuable information to support guidelines of physical activity for people to improve musculoskeletal health, especially post-menopausal women. The scientific questions that will be investigated are:

  1. What are the acute effects of the daily timing of exercise on serum concentrations of bone turnover markers and 24-h total urinary calcium excretion?
  2. Are differences in initial exercise-induced responses of bone turnover markers and urinary Ca excretion maintained across two weeks of exercise training?
02

Conditions studied

  • Overweight

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 2 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Morning Exercise

    Morning exercise session

    Other: Morning Exercise

  • Experimental
    Evening Exercise

    Evening exercise session

    Other: Evening Exercise

Interventions

  • OtherMorning Exercise

    Standardized treadmill exercise session starting at approximately 0700

  • OtherEvening Exercise

    Standardized treadmill exercise session starting at approximately 1800

06

What researchers measure

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.

    Time frame: Day 1, Day 15

07

Study locations

1 site
  • USDA Grand Forks Human Nutrition Research Center
    Grand Forks, North Dakota 58203, United States
08

References and documents

Study documents

  • Informed consent form · May 3, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05612412
Lead sponsor
USDA Grand Forks Human Nutrition Research Center
Responsible party
Sponsor
First posted
Nov 10, 2022
Start date
Oct 5, 2023
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
Apr 11, 2025

Study contacts

Jay Cao, PhD
principal investigator · USDA Grand Forks Human Nutrition Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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