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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Resorption, Bone and Bones

Intervention / Treatment
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* Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement
* Dietary Supplement: Placebo Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement<br>Fava-Bean Protein Concentrate and Aquamin F | Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement<br>* 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<br>|
| Placebo Comparator: Placebo Control<br>Placebo Control | Dietary Supplement: Placebo Control<br>* Ingestion of the Control Product at 07.00am - 500ml water volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in regulator of bone metabolism - Parathyroid hormone | The magnitude and time course of the acute change (0-4 hours) in plasma parathyroid hormone (PTH) measured in pmol/L. | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | 
| Change in ionized calcium and potassium. | The magnitude and time course of the acute change (0-4 hours) 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 total plasma 25 (OH)D level | Pre-ingestion (Plasma) | 
| Change in insulin and glucose | The magnitude and time course of the acute change (0-4 hours) in plasma insulin and glucose | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | 
| Change in incretin peptides | 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. | Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, plant, marine, protein, bone, skeletal, health, dietary supplements, sustainable