## Protocol Section
### Identification Module
**NCT ID:** NCT01757379

**Brief Title:** Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans

**Official Title:** Evaluation of the Bioavailability and Production of Short Chain Fatty Acids in the Colon. A Stable Isotope Study in Healthy Humans.

#### Organization Study ID Info
**ID:** ML5768
#### Organization
**Class:** OTHER
**Full Name:** KU Leuven
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-04

**Type:** ACTUAL

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2012-12-28
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-21
**Study First Submit QC Date:** 2012-12-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** KU Leuven

#### Responsible Party

**Investigator Affiliation:** KU Leuven

**Investigator Full Name:** Kristin Verbeke

**Investigator Title:** Professor K. Verbeke

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to evaluate the bioavailability of acetate, propionate and butyrate in healthy humans using a stable isotope technology.

In addition the level of acetate, propionate and butyrate production from inulin will be determined using the principle of isotope dilution.

### Conditions Module

**Conditions:**

- Short Chain Fatty Acids Bioavailability

**Keywords:**

- Short chain fatty acids

- Acetate

- Propionate

- Butyrate

- Bioavailability

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Dietary Supplement: 13C-labeled Acetate

**Label:** 13C-labeled acetate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Dietary Supplement: 13C-labeled propionate

**Label:** 13C-labeled propionate

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Dietary Supplement: 13C-labeled butyrate

**Label:** 13C-labeled butyrate

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Dietary Supplement: Inulin

**Label:** Inulin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 13C-labeled acetate

**Description:** 400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)

**Name:** 13C-labeled Acetate

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- 13C-labeled propionate

**Description:** 340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)

**Name:** 13C-labeled propionate

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- 13C-labeled butyrate

**Description:** 990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)

**Name:** 13C-labeled butyrate

**Type:** DIETARY_SUPPLEMENT

#### Intervention 4

**Arm Group Labels:**

- Inulin

**Description:** 15 g of inulin dissolved in 200 ml of water

**Name:** Inulin

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Participants performed each 4 test days and they were followed each test day for 12 hours, with sample collections at regular time points. Blood samples were collected every hour during the first 4 hours and afterwards every 20 minutes during 8 hours. Urine samples were collected during 24h in different fractions: 0-4h, 4-8h, 8-12h, 12-24h.

**Measure:** Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples

**Time Frame:** 12 hours each test day and 4 test days/volunteer

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy volunteers
* Regular dietary pattern (3 meals/day)
* Age: 18-65y
* BMI: 18,5-27 kg/m2

Exclusion Criteria:

* Intake of antibiotics 1 month prior to the study
* Abdominal surgery in the past, with the exception of appendectomy
* Intake of medication influencing the gastro-intestinal system 14 days prior to the study
* In treatment at a dietician
* Intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study
* Serious chronic disease of the gastrointestinal tract
* Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study
* Pregnancy, pregnancy desire or lactation
* Blood donation during the last 3 months prior to the study
* Diabetes (type 1 or 2)
* Aberrant hemoglobin level (Hb) in blood. Normal between 14.0 and 18.0 g/dL for men and between 12.0 and 16.0 g/dL for women

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Leuven

**Country:** Belgium

**Facility:** KU Leuven/ UZ Leuven

**State:** Vlaams-Brabant

**Zip:** 3000

#### Overall Officials

**Official 1:**

**Affiliation:** KU Leuven

**Name:** Kristin Verbeke, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: T401

- Name: Inulin

- Relevance: HIGH

- As Found: Sildenafil

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
