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

Primary Purpose

Bone Resorption, Bone and Bones

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement
Placebo Control
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Resorption focused on measuring nutrition, plant, marine, protein, bone, skeletal, health, dietary supplements, sustainable

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Education & Health Sciences, University of Limerick,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Placebo Control

Arm Description

Fava-Bean Protein Concentrate and Aquamin F

Placebo Control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in ionized calcium and potassium.
The magnitude and time course of the acute change (0-4 hours) in ionized calcium and potassium.
Vitamin D Status
Pre-ingestion total plasma 25 (OH)D level
Change in insulin and glucose
The magnitude and time course of the acute change (0-4 hours) in plasma insulin and glucose
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.

Full Information

First Posted
September 5, 2022
Last Updated
January 17, 2023
Sponsor
University of Limerick
Collaborators
Marigot Ltd., Enterprise Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05533502
Brief Title
Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement and Bone Remodeling in Young Adults
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Limerick
Collaborators
Marigot Ltd., Enterprise Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Bone and Bones
Keywords
nutrition, plant, marine, protein, bone, skeletal, health, dietary supplements, sustainable

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Investigator
Masking Description
Single Blind Study (Investigator only)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement
Arm Type
Active Comparator
Arm Description
Fava-Bean Protein Concentrate and Aquamin F
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Placebo Control
Intervention Type
Dietary Supplement
Intervention Name(s)
Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control
Intervention Description
Ingestion of the Control Product at 07.00am - 500ml water volume.
Primary Outcome Measure Information:
Title
Bone turnover
Description
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.
Time Frame
Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)
Secondary Outcome Measure Information:
Title
Change in regulator of bone metabolism - Parathyroid hormone
Description
The magnitude and time course of the acute change (0-4 hours) in plasma parathyroid hormone (PTH) measured in pmol/L.
Time Frame
Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)
Title
Change in ionized calcium and potassium.
Description
The magnitude and time course of the acute change (0-4 hours) in ionized calcium and potassium.
Time Frame
Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Whole Blood)
Title
Vitamin D Status
Description
Pre-ingestion total plasma 25 (OH)D level
Time Frame
Pre-ingestion (Plasma)
Title
Change in insulin and glucose
Description
The magnitude and time course of the acute change (0-4 hours) in plasma insulin and glucose
Time Frame
Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)
Title
Change in incretin peptides
Description
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.
Time Frame
Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M Jakeman, PhD
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Education & Health Sciences, University of Limerick,
City
Limerick
ZIP/Postal Code
V94 T9PX
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://aquamin.com/products/marine-minerals-aquamin-f/
Description
Related Info
URL
https://aturaproteins.com/plant-proteins/fava-bean-protein/
Description
Related Info

Learn more about this trial

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

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