OverweightNCT05612412
Exercise for Better Bones - Day or Night?
A study testing Morning Exercise and Evening Exercise in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Morning Exercise and Evening Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Bone Metabolic Responses to Morning Versus Evening Exercise
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:
- 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?
- Are differences in initial exercise-induced responses of bone turnover markers and urinary Ca excretion maintained across two weeks of exercise training?
- Conditions
- Overweight
- Being tested
- Morning Exercise, Evening Exercise
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning ExerciseOther
Standardized treadmill exercise session starting at approximately 0700
Evening ExerciseOther
Standardized treadmill exercise session starting at approximately 1800
| Study group | Role | What they receive |
|---|---|---|
| Morning Exercise | Experimental | Morning exercise session Receives: Other: Morning Exercise |
| Evening Exercise | Experimental | Evening exercise session Receives: Other: Evening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start5 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jay Cao, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612412
- Sponsor's protocol ID
- GFHNRC154
- Status last verified
- Apr 2025
- First submitted
- 3 Nov 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metabolic Responses to Morning Versus Evening Exercise
- ClinicalTrials.gov ID
- NCT05612412
- Acronym / sponsor ID
- GFHNRC154
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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?
- Are differences in initial exercise-induced responses of bone turnover markers and urinary Ca excretion maintained across two weeks of exercise training?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Exercise | Experimental | Other: Morning ExerciseMorning exercise session |
| Evening Exercise | Experimental | Other: Evening ExerciseEvening exercise session |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning ExerciseStandardized treadmill exercise session starting at approximately 0700 | Other | Morning Exercise |
| Evening ExerciseStandardized treadmill exercise session starting at approximately 1800 | Other | Evening Exercise |
Primary outcome
Change in serum C-terminal telopeptide of type 1 collagen (CTX)
Time frame: Day 1, Day 15
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.
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Cao, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Exercise and Evening Exercise in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum C-terminal telopeptide of type 1 collagen (CTX) (time frame: Day 1, Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.