Healthy AdultsNCT06359483
The Impact of Meal Frequency on Bone Remodeling in Healthy Adults
A study testing Meal Frequency Manipulation in people with Healthy Adults, run by University of Jordan at 1 site in Jordan.
Trial summary
The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Meal Frequency Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- 19 Jun 2021to 4 Jul 2021
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals aged between 19 and 30 years
- Absence of medical conditions affecting bone remodeling, including:
- Hyper/hypothyroidism
- Diabetes
- Cancer
- Renal problems
Show all 16Show fewer
- Paget's disease
- Cushing's disease
- Multiple myeloma
- Rickets
- Osteomalacia
- Hypogonadism
- Osteoporosis
- Metastatic carcinoma
- Gaucher's disease
- Hairy cell leukemia
Who cannot join
- Abnormal food habits, including:
- Night eating or frequent diet changes
- Shift work
- Daytime sleepers
- Irregular sleeping patterns
- Use of medications or supplements impacting bone remodeling, calcium homeostasis, or sleep patterns
- History of a broken or fractured bone within the last 6 months before the study
- Exclusively enlisting male volunteers to eliminate the potential influence of maternal hormones, such as estrogen, on bone remodeling dynamics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study on the Short-Term Impact of Meal Frequency on Bone Remodeling in Healthy Adults
The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism.
Read the detailed description
The study looked into how meal frequency influences bone remodeling, focusing on the Procollagen Type 1 N-terminal propeptide (P1NP) marker, which indicates bone production. Bone remodeling is a continual process in which osteoclasts break down bone tissue and osteoblasts form new bone tissue. Dietary patterns are increasingly recognized as influencing bone remodeling and general bone health, with meal frequency playing an important role in bone metabolism.
To perform the study, 30 healthy adult males aged 19 to 30 were recruited from Jordan using informational flyers. They participated in a randomized controlled intervention experiment. The participants were randomly allocated to one of two groups: one group ate three meals per day and the other ate eight meals per day. This dietary pattern was followed for three consecutive days in what was referred to as Phase 1 of the study.
Following Phase 1, there was a one-week washout phase to remove any residual effects from the previous food pattern. Following the washout period, the participants were moved to an alternate meal frequency (i.e., those who had three meals per day were now eating eight, and vice versa) for another three days, known as Phase 2.
Blood samples were collected from participants at baseline (before beginning the food intervention) and after each phase of the trial. The levels of P1NP in the blood samples were determined using an enzyme-linked immunosorbent assay (ELISA), a widely used laboratory technique for detecting and quantifying chemicals.
- Conditions
- Healthy Adults
- Being tested
- Meal Frequency Manipulation
- Keywords
- Bone Remodelling, P1NP, Bone Turnover Biomarkers, Meal Frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal Frequency ManipulationOther
The intervention involves altering meal frequency among participants. One group consumes three standardized meals per day, while the other consumes eight smaller, more frequent meals. Meals are designed to meet nutritional needs and adhere to dietary guidelines. The aim is to assess the impact of meal frequency on bone remodeling by measuring the blood biomarker P1NP at various points during the study.
| Study group | Role | What they receive |
|---|---|---|
| Three Meals/Day Phase | Experimental | Participants in this arm consumed three meals daily, each providing a standardized amount of calories and macronutrients. Meals were served at specific times throughout the day, and blood samples were collected at baseline, after the last day of Phase 1, and after the last day of Phase 2. This arm aimed to investigate the impact of consuming three meals daily on bone remodeling and P1NP levels. Receives: Other: Meal Frequency Manipulation |
| Eight Meals/Day Phase | Experimental | Participants in this arm consumed eight meals per day, with smaller portions served more frequently throughout the day than the three-meals-per-day arm. Each meal provided a standardized amount of calories and macronutrients. Blood samples were collected at the same time points as in the three-meals-per-day arm. This arm aimed to compare the effects of consuming eight meals per day versus three meals per day on bone remodeling and P1NP levels. Receives: Other: Meal Frequency Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels."
P1NP is a biomarker that reflects bone formation activity, making it a key indicator of bone remodeling processes. The primary focus of the study is to analyze changes in P1NP levels in response to alterations in meal frequency, comparing levels at baseline with those observed after different meal frequency interventions. These measurements allow researchers to assess the impact of meal frequency on bone remodeling dynamics and overall bone health.
Measured: Two phases of three consecutive days with a one-week washout period. Phase 1 involved random assignment to three or eight meals per day, followed by Phase 2 with a switch in meal frequencies. Blood samples were taken at baseline and after each phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start19 Jun 2021
- Primary completion4 Jul 2021
- Study completion4 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- United Arab Emirates University
- Responsible party
- Principal investigator, Laila Albardan, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359483
- Sponsor's protocol ID
- 108/2021
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study on the Short-Term Impact of Meal Frequency on Bone Remodeling in Healthy Adults
- ClinicalTrials.gov ID
- NCT06359483
- Acronym / sponsor ID
- 108/2021
- Conditions
- Healthy Adults
- Keywords
- Bone Remodelling, P1NP, Bone Turnover Biomarkers, Meal Frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- United Arab Emirates University
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 4 Jul 2021 (actual)
- Study completion
- 4 Jul 2021 (actual)
- First posted
- 11 Apr 2024 (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 study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism.
Detailed description
The study looked into how meal frequency influences bone remodeling, focusing on the Procollagen Type 1 N-terminal propeptide (P1NP) marker, which indicates bone production. Bone remodeling is a continual process in which osteoclasts break down bone tissue and osteoblasts form new bone tissue. Dietary patterns are increasingly recognized as influencing bone remodeling and general bone health, with meal frequency playing an important role in bone metabolism.
To perform the study, 30 healthy adult males aged 19 to 30 were recruited from Jordan using informational flyers. They participated in a randomized controlled intervention experiment. The participants were randomly allocated to one of two groups: one group ate three meals per day and the other ate eight meals per day. This dietary pattern was followed for three consecutive days in what was referred to as Phase 1 of the study.
Following Phase 1, there was a one-week washout phase to remove any residual effects from the previous food pattern. Following the washout period, the participants were moved to an alternate meal frequency (i.e., those who had three meals per day were now eating eight, and vice versa) for another three days, known as Phase 2.
Blood samples were collected from participants at baseline (before beginning the food intervention) and after each phase of the trial. The levels of P1NP in the blood samples were determined using an enzyme-linked immunosorbent assay (ELISA), a widely used laboratory technique for detecting and quantifying chemicals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three Meals/Day Phase | Experimental | Other: Meal Frequency ManipulationParticipants in this arm consumed three meals daily, each providing a standardized amount of calories and macronutrients. Meals were served at specific times throughout the day, and blood samples were collected at baseline, after the last day of Phase 1, and after the last day of Phase 2. This arm aimed to investigate the impact of consuming three meals daily on bone remodeling and P1NP levels. |
| Eight Meals/Day Phase | Experimental | Other: Meal Frequency ManipulationParticipants in this arm consumed eight meals per day, with smaller portions served more frequently throughout the day than the three-meals-per-day arm. Each meal provided a standardized amount of calories and macronutrients. Blood samples were collected at the same time points as in the three-meals-per-day arm. This arm aimed to compare the effects of consuming eight meals per day versus three meals per day on bone remodeling and P1NP levels. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy individuals aged between 19 and 30 years
- Absence of medical conditions affecting bone remodeling, including:
Key exclusion criteria (8 listed)
- Abnormal food habits, including:
- Use of medications or supplements impacting bone remodeling, calcium homeostasis, or sleep patterns
- History of a broken or fractured bone within the last 6 months before the study
- Exclusively enlisting male volunteers to eliminate the potential influence of maternal hormones, such as estrogen, on bone remodeling dynamics
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 |
|---|---|---|
| Meal Frequency ManipulationThe intervention involves altering meal frequency among participants. One group consumes three standardized meals per day, while the other consumes eight smaller, more frequent meals. Meals are designed to meet nutritional needs and adhere to dietary guidelines. The aim is to assess the impact of meal frequency on bone remodeling by measuring the blood biomarker P1NP at various points during the study. | Other | Eight Meals/Day Phase, Three Meals/Day Phase |
Primary outcome
The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels."
Time frame: Two phases of three consecutive days with a one-week washout period. Phase 1 involved random assignment to three or eight meals per day, followed by Phase 2 with a switch in meal frequencies. Blood samples were taken at baseline and after each phase.
P1NP is a biomarker that reflects bone formation activity, making it a key indicator of bone remodeling processes. The primary focus of the study is to analyze changes in P1NP levels in response to alterations in meal frequency, comparing levels at baseline with those observed after different meal frequency interventions. These measurements allow researchers to assess the impact of meal frequency on bone remodeling dynamics and overall bone health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Frequency Manipulation in people with Healthy Adults, run by University of Jordan at 1 site in Jordan.
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 16 inclusion and 8 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: finished, as of the sponsor's last update on 11 Apr 2024. 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 Jordan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels." (time frame: Two phases of three consecutive days with a one-week washout period. Phase 1 involved random assignment to three or eight meals per day, followed by Phase 2 with a switch in meal frequencies. Blood samples were taken at baseline and after each phase.). 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 2024.