Clinical trial NCT06359483: The Impact of Meal Frequency on Bone Remodeling in Healthy Adults
Official title: A Randomized Controlled Pilot Study on the Short-Term Impact of Meal Frequency on Bone Remodeling in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Bone Remodelling
P1NP
Bone Turnover Biomarkers
Meal Frequency
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: United Arab Emirates University
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy individuals aged between 19 and 30 years
2. Absence of medical conditions affecting bone remodeling, including:

   * Hyper/hypothyroidism
   * Diabetes
   * Cancer
   * Renal problems
   * Paget's disease
   * Cushing's disease
   * Multiple myeloma
   * Rickets
   * Osteomalacia
   * Hypogonadism
   * Osteoporosis
   * Metastatic carcinoma
   * Gaucher's disease
   * Hairy cell leukemia

Exclusion Criteria:

1. Abnormal food habits, including:

   * Night eating or frequent diet changes
   * Shift work
   * Daytime sleepers
   * Irregular sleeping patterns
2. Use of medications or supplements impacting bone remodeling, calcium homeostasis, or sleep patterns
3. History of a broken or fractured bone within the last 6 months before the study
4. Exclusively enlisting male volunteers to eliminate the potential influence of maternal hormones, such as estrogen, on bone remodeling dynamics

Primary outcomes:
measure: The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels."
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
References: