Bone and Bones, Bone Resorption
Conditions
Keywords
nutrition, plant, marine, protein, bone, skeletal, health, dietary supplements, sustainable
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.
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.
Interventions
DIETARY_SUPPLEMENTCombined 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_SUPPLEMENTPlacebo Control
Ingestion of the Control Product at 07.00am - 500ml water volume.
Sponsors
Marigot Ltd.
Enterprise Ireland
University of Limerick
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Single Blind Study (Investigator only)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone turnover | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in regulator of bone metabolism - Parathyroid hormone | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | The magnitude and time course of the acute change (0-4 hours) in plasma parathyroid hormone (PTH) measured in pmol/L. |
| Change in ionized calcium and potassium. | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Whole Blood) | The magnitude and time course of the acute change (0-4 hours) in ionized calcium and potassium. |
| Vitamin D Status | Pre-ingestion (Plasma) | Pre-ingestion total plasma 25 (OH)D level |
| Change in insulin and glucose | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | The magnitude and time course of the acute change (0-4 hours) in plasma insulin and glucose |
| Change in incretin peptides | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | The magnitude and time course of the acute change (0-4 hours) in enterogastric peptide glucose-dependent insulinotropic peptide (GIP1-42) measured in pg/mL, glucagon-like peptide-1 (GLP-17-36) measured in pg/mL and GLP-2 (1-33) measured in pg/mL. |
Countries
Ireland
Outcome results
None listed