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Exercise for Better Bones - Day or Night?

Primary Purpose

Overweight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning Exercise
Evening Exercise
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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: 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

Sites / Locations

  • USDA Grand Forks Human Nutrition Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Morning Exercise

Evening Exercise

Arm Description

Morning exercise session

Evening exercise session

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2022
Last Updated
October 17, 2023
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05612412
Brief Title
Exercise for Better Bones - Day or Night?
Official Title
Bone Metabolic Responses to Morning Versus Evening Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morning Exercise
Arm Type
Experimental
Arm Description
Morning exercise session
Arm Title
Evening Exercise
Arm Type
Experimental
Arm Description
Evening exercise session
Intervention Type
Other
Intervention Name(s)
Morning Exercise
Intervention Description
Standardized treadmill exercise session starting at approximately 0700
Intervention Type
Other
Intervention Name(s)
Evening Exercise
Intervention Description
Standardized treadmill exercise session starting at approximately 1800
Primary Outcome Measure Information:
Title
Change in serum C-terminal telopeptide of type 1 collagen (CTX)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Cao, PhD
Phone
701-795-8377
Email
jay.cao@usda.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Cao, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela J Scheett, MPH, RD
Phone
701-795-8386
Email
angela.scheett@usda.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies

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Exercise for Better Bones - Day or Night?

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