## Protocol Section
### Identification Module
**NCT ID:** NCT06435637

**Acronym:** CODIAK

**Brief Title:** Effects of Ingesting Multiple Boluses of Collagen on Muscle & Skin Connective Protein Synthesis in Vivo in Humans

**Official Title:** Collagen Digestion and Amino Acid Absorption Kinetics and the Effect on Muscle & Skin

#### Organization Study ID Info
**ID:** METC 22-018
#### Organization
**Class:** OTHER
**Full Name:** Maastricht University Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-22
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Maastricht University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.

Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.

Study design: Double-blind, parallel-group, placebo-controlled intervention study.

Study population: 20 healthy young males, aged 18-35 years.

Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.

Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.

### Conditions Module

**Conditions:**

- Muscle Protein Synthesis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Double-blind, parallel-group, placebo-controlled intervention study

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 27

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 100 g of collagen peptides (in boluses) with vitamin C

**Intervention Names:**

- Dietary Supplement: Collagen protein

- Behavioral: Resistance exercise

**Label:** Collagen protein

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Non-caloric placebo (flavoured water) drinks, with vitamin C.

**Intervention Names:**

- Behavioral: Resistance exercise

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Collagen protein

**Description:** Ingestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise

**Name:** Collagen protein

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Collagen protein

- Placebo

**Description:** A single resistance exercise session of the leg press and leg extension exercise

**Name:** Resistance exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** age in years

**Measure:** Age

**Time Frame:** baseline

**Description:** assessed by written dietary intake records

**Measure:** Dietary macronutrient intake

**Time Frame:** 2 days before test days

**Description:** body mass in kg

**Measure:** Body mass

**Time Frame:** baseline

**Description:** Height in m

**Measure:** Height

**Time Frame:** baseline

**Description:** Measured by DXA

**Measure:** Lean mass

**Time Frame:** baseline

**Description:** maximum strength of both legs

**Measure:** One repetition maximum of the legs

**Time Frame:** baseline

#### Primary Outcomes

**Description:** The primary analysis will be an independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.

**Measure:** Muscle connective protein synthesis rates rested leg

**Time Frame:** one value calculated over 8 hours

#### Secondary Outcomes

**Description:** Independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.

**Measure:** Muscle connective protein synthesis rates exercised leg

**Time Frame:** one value calculated over 8 hours

**Description:** Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.

**Measure:** Myofibrillar protein synthesis rates rested leg

**Time Frame:** one value calculated over 8 hours

**Description:** Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.

**Measure:** Myofibrillar protein synthesis rates exercised leg

**Time Frame:** one value calculated over 8 hours

**Description:** Independent t-test, comparing postprandial skin protein synthesis rates over the 0-8 h period (i.e., one integrated value).

**Measure:** Skin protein synthesis rates

**Time Frame:** one value calculated over 8 hours

**Description:** Plasma insulin concentrations

**Measure:** Plasma insulin concentrations

**Time Frame:** measured over the 8 hour post-prandial period

**Description:** Plasma amino acids concentrations

**Measure:** Plasma amino acids concentrations

**Time Frame:** measured over the 8 hour post-prandial period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged between 18-35 years
* Male
* Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
* 18.5 ≤ BMI ≤ 30 kg/m2
* No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

Exclusion Criteria:

* Female
* Smoking
* Musculoskeletal disorders
* Metabolic disorders
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
* Chronic use of gastric acid suppressing medication or anti-coagulants
* Unstable weight over the last three months
* Diagnosed GI tract disorders or diseases
* Blood donation in the past 2 months

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** l.vanloon@maastrichtuniversity.nl

**Name:** Luc JC van Loon, PhD

**Phone:** +31-43-3881397

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Maastricht

**Contacts:**

***Contact 1:***

- **Email:** t.aussieker@maastrichtuniversity.nl

- **Name:** Thorben Aussieker, MSc

- **Role:** CONTACT

***Contact 2:***

- **Name:** Luc JC van Loon, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Netherlands

**Facility:** Maastricht University Medical Centre

**Zip:** 6200 MD

#### Overall Officials

**Official 1:**

**Affiliation:** Maastricht University

**Name:** Luc JC van Loon, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M4513

- Name: Ascorbic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T477

- Name: Vitamin C

- Relevance: LOW

- As Found: Unknown

- ID: T437

- Name: Ascorbic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
