NCT05533502

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

Acute Effects of a Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement on Postprandial Gut Hormones and Bone Remodeling in Young Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Limerick · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

A block-randomized, within-subject, two-day, crossover design examining acute (0-4 hour) postprandial changes in different gut-derived hormone concentrations and biomarkers of bone metabolism in 12 healthy, young adults following ingestion of a combination plant-based protein and marine-based multi-mineral supplement or control. Each participant will consume (in a random manner) either one of two investigational products (i.e., combined nutritional supplement or control). The combined nutritional supplement will consist of: 0.3 g/kg body mass of ATURA Fava-Bean Protein and 800mg of Aquamin F (a highly bioactive source of minerals rich in calcium) dissolved in 500ml water volume. The control product will consist of 500ml water volume without the protein and multi-mineral nutritional composition.

Conditions

• Bone Resorption
• Bone and Bones

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Combined Plant-Based Protein and Marine-Based Multi-Mineral 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	Placebo Control	Ingestion of the Control Product at 07.00am - 500ml water volume.

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-09-09
• Last updated: 2023-12-19

Locations

1 site across 1 country: Ireland