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Completed

NCT Number: NCT05533502

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

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.

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Key information

Conditions

Bone Resorption Bone And Bones Bone Diseases Musculoskeletal Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Education & Health Sciences, University of Limerick,

Limerick, V94 T9PX, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo Control

Dietary Supplement

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

Primary outcomes

  1. Bone turnover

    Time frame: 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 outcomes

  1. Change in regulator of bone metabolism - Parathyroid hormone

    Time frame: 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.

  2. Change in ionized calcium and potassium.

    Time frame: 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.

  3. Vitamin D Status

    Time frame: Pre-ingestion (Plasma)

    Pre-ingestion total plasma 25 (OH)D level

  4. Change in insulin and glucose

    Time frame: 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

  5. Change in incretin peptides

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Enterprise Ireland
  • Marigot Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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