Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement and Bone Remodeling in Young Adults

NCT05533502 | Completed

• 1 other identifier: 2022_03_06_EHS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Nutrient intake of calcium and protein are known to function as regulators of bone remodeling. Specifically, a balanced rate of bone resorption and bone formation (i.e. bone remodeling process) is required to maintain bone health. However, a high remodeling rate, or an imbalance between formation and resorption, as well as suboptimal nutrient intake are known to contribute to fracture risk and bone dysfunction. Gut-derived hormones represent an important link between nutrient intake and bone remodeling (i.e. gut-bone axis). A sustainable nutritional intervention that positively modulates the postprandial responses of gut-derived hormones and the linked bone remodeling processes is an attractive option for the optimization of bone health in young adults. The proposed nutrient intervention seeks to explore the bioefficacy of a combination plant-based protein and marine-based multi-mineral supplement following oral ingestion in young, healthy men and women. A postprandial time-course study will be undertaken to examine the acute effects and/or associations between different gut-derived hormones and biomarkers of bone metabolism.

Conditions

Bone Resorption; Bone and Bones

Keywords

nutrition; plant; marine; protein; bone; skeletal; health; dietary supplements; sustainable

Outcome Measures

Primary Outcomes (1)

• Bone turnover

  A balance of the difference between the magnitude and time course of the acute change (0-4 hours) in plasma C-terminal telopeptide of type 1 collagen (CTX) in ng/mL, a measure of bone resorption, and procollagen type 1 amino-terminal propeptide (P1NP) in ng/ml, a measure of bone formation.

  Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)

Secondary Outcomes (5)

• Change in regulator of bone metabolism - Parathyroid hormone

  Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)

• Change in ionized calcium and potassium.

  Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Whole Blood)

• Vitamin D Status

  Pre-ingestion (Plasma)

• Change in insulin and glucose

  Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)

• Change in incretin peptides

  Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)

Study Arms (2)

Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement

ACTIVE COMPARATOR

Fava-Bean Protein Concentrate and Aquamin F

Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement

Placebo Control

PLACEBO COMPARATOR

Placebo Control

Dietary Supplement: Placebo Control

Interventions

Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement DIETARY_SUPPLEMENT

Ingestion of the Test Product at 07.00am - Fava-bean protein concentrate dosed at 0.33 g/kg body mass and Aquamin F dosed at 800mg in 500 ml water volume. Supplied by Marigot Limited, Strand Farm Currabinny, Co. Cork, Ireland

Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement

Placebo Control DIETARY_SUPPLEMENT

Ingestion of the Control Product at 07.00am - 500ml water volume.

Placebo Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 35 years.
• Recreationally active (150-300 min/week of moderate physical activity).
• Healthy (i.e.,not presenting with injury, illness, medication, history of chronic disease, or known allergies/intolerance (e.g. favism) to the ingredients contained in either formulation.

Sponsors & Collaborators

• University of Limerick: lead
• Marigot Ltd.: collaborator
• Enterprise Ireland: collaborator

Study Sites (1)

Faculty of Education & Health Sciences, University of Limerick,

Limerick, V94 T9PX, Ireland

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Philip M Jakeman, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single Blind Study (Investigator only)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A block-randomized, within-subject, two-day, crossover design examining acute (0-4 h) postprandial changes in different gut hormone concentrations and bone remodeling biomarkers in 12 healthy, young adults following ingestion of a combination plant-based protein and marine-based multi-mineral supplement or control.

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: September 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 19, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)