The Impact of Meal Frequency on Bone Remodeling in Healthy Adults

NCT06359483 | Completed

• 1 other identifier: 108/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

Bone Remodelling; P1NP; Bone Turnover Biomarkers; Meal Frequency

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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.

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.

Other: Meal Frequency Manipulation

Interventions

Meal Frequency Manipulation OTHER

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.

Eight Meals/Day Phase; Three Meals/Day Phase

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals aged between 19 and 30 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead
• United Arab Emirates University: collaborator

Study Sites (1)

University of Jordan

Amman, Jordan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 11, 2024
• Study Start: June 19, 2021
• Primary Completion: July 4, 2021
• Study Completion: July 4, 2021
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

JO (1)