Effect of Fibre Supplementation on Mixed-meal Challenge Response

NCT04829396 | Completed

• 2 other identifiers: CHDR1901NL71723.056.19
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Improving healthy physiological processes through nutritional intervention, as opposed to restoring physiology after disease occurrence, is an important new avenue for the reduction of disease burden in the population. A relatively new target for interventions is the gut microbiome. Dietary fibre is a nutritional intervention shown to alter gut microbiome and function. The present study aims to elucidate the relationship between microbiome modulation with dietary fibre and health. In order to assess health improvement, a meal challenge will be given to characterize the physiological processes and their resilience to challenge in healthy volunteers before and after microbiome modulation.

Conditions

Health Status

Keywords

Fibre; Gut microbiome; Meal challenge; Microvasculature

Outcome Measures

Primary Outcomes (56)

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 4

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 8

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 12

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 16

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 20

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 24

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 28

• Microbiome changes

  Microbiome changes measured using 16S rRNA sequencing

  Change from Baseline microbiome changes at week 32

• Non-esterified fatty acids (NEFAs)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to non-esterified fatty acids (NEFAs)

  Change from Baseline at week 12

• Non-esterified fatty acids (NEFAs)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to non-esterified fatty acids (NEFAs)

  Change from Baseline at week 20

• Non-esterified fatty acids (NEFAs)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to non-esterified fatty acids (NEFAs)

  Change from Baseline at week 32

• Glucose

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to glucose

  Change from Baseline at week 12

• Glucose

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to glucose

  Change from Baseline at week 20

• Glucose

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to glucose

  Change from Baseline at week 32

• Insulin

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to insulin

  Change from Baseline at week 12

• Insulin

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to insulin

  Change from Baseline at week 20

• Insulin

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to insulin

  Change from Baseline at week 32

• Triglycerides (TG)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to triglycerides (TG)

  Change from Baseline at week 12

• Triglycerides (TG)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to triglycerides (TG)

  Change from Baseline at week 20

• Triglycerides (TG)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to triglycerides (TG)

  Change from Baseline at week 32

• High-density lipoprotein (HDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-density lipoprotein (HDL)

  Change from Baseline at week 12

• High-density lipoprotein (HDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-density lipoprotein (HDL)

  Change from Baseline at week 20

• High-density lipoprotein (HDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-density lipoprotein (HDL)

  Change from Baseline at week 32

• Low-density lipoprotein (LDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to low-density lipoprotein (LDL)

  Change from Baseline at week 12

• Low-density lipoprotein (LDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to low-density lipoprotein (LDL)

  Change from Baseline at week 20

• Low-density lipoprotein (LDL)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to low-density lipoprotein (LDL)

  Change from Baseline at week 32

• Total cholesterol

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to total cholesterol.

  Change from Baseline at week 12

• Total cholesterol

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to total cholesterol.

  Change from Baseline at week 20

• Total cholesterol

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to total cholesterol.

  Change from Baseline at week 32

• Interleukin-6

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-6

  Change from Baseline at week 32

• Interleukin-6

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-6

  Change from Baseline at week 12

• Interleukin-6

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-6

  Change from Baseline at week 20

• Interleukin-8

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-8

  Change from Baseline at week 12

• Interleukin-8

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-8

  Change from Baseline at week 20

• Interleukin-8

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-8

  Change from Baseline at week 32

• Interleukin-10

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-10

  Change from Baseline at week 12

• Interleukin-10

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-10

  Change from Baseline at week 20

• Interleukin-10

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to interleukin-10

  Change from Baseline at week 32

• Tumour necrosis factor alpha (TNF-α)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to tumour necrosis factor alpha (TNF-α).

  Change from Baseline at week 12

• Tumour necrosis factor alpha (TNF-α)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to tumour necrosis factor alpha (TNF-α).

  Change from Baseline at week 20

• Tumour necrosis factor alpha (TNF-α)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to tumour necrosis factor alpha (TNF-α).

  Change from Baseline at week 32

• High-sensitivity C-reactive protein (hs-CRP)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein (hs-CRP)

  Change from Baseline at week 12

• High-sensitivity C-reactive protein (hs-CRP)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein (hs-CRP)

  Change from Baseline at week 20

• High-sensitivity C-reactive protein (hs-CRP)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein (hs-CRP)

  Change from Baseline at week 32

• Serum amyloid A (SAA)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited serum amyloid A (SAA)

  Change from Baseline at week 12

• Serum amyloid A (SAA)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited serum amyloid A (SAA)

  Change from Baseline at week 20

• Serum amyloid A (SAA)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited serum amyloid A (SAA)

  Change from Baseline at week 32

• Alanine aminotransferase (ALT)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to alanine aminotransferase (ALT)

  Change from Baseline at week 12

• Alanine aminotransferase (ALT)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to alanine aminotransferase (ALT)

  Change from Baseline at week 20

• Alanine aminotransferase (ALT)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to alanine aminotransferase (ALT)

  Change from Baseline at week 32

• Aspartate aminotransferase (AST)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to aspartate aminotransferase (AST)

  Change from Baseline at week 12

• Aspartate aminotransferase (AST)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to aspartate aminotransferase (AST)

  Change from Baseline at week 20

• Aspartate aminotransferase (AST)

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to aspartate aminotransferase (AST)

  Change from Baseline at week 32

• Gamma-glutamyltransferase (GGT).

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to gamma-glutamyltransferase (GGT).

  Change from Baseline at week 12

• Gamma-glutamyltransferase (GGT).

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to gamma-glutamyltransferase (GGT).

  Change from Baseline at week 20

• Gamma-glutamyltransferase (GGT).

  Response to challenge of metabolic and inflammatory biomarkers including but not limited to gamma-glutamyltransferase (GGT).

  Change from Baseline at week 32

Study Arms (2)

Fibre mixture

EXPERIMENTAL

Dietary supplement. A mixture of fibres will be administered consisting of 10g of acacia gum powder and 3g of carrot powder. The study product is a fibre mixture consisting of a mix of 10 g of Acacia Gum and 3 g of carrot fibre taken p.o. o.d. in powder form for a total of approximately 10 g of dietary fibre per day.

Dietary Supplement: Fibre mixture

Placebo for Fibre mixture

PLACEBO COMPARATOR

A placebo of the mixture of fibres will be administered.

Other: placebo

Interventions

placebo OTHER

Powder consisting of 13 g of digestible carbohydrates with similar appearance as the investigational fibre mixture.

Placebo for Fibre mixture

Fibre mixture DIETARY_SUPPLEMENT

The study product is a fibre mixture consisting of a mix of 10 g of Acacia Gum and 3 g of carrot fibre taken p.o. o.d. in powder form for a total of approximately 10 g of dietary fibre per day.

Fibre mixture

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study-mandated procedure.
• Healthy male or female subjects, between 45 and 70 years of age, inclusive.
• Female subjects must be of non-childbearing potential (postmenopausal for at least 12 months prior to screening or documented surgically sterile).
• BMI 25-30 kg/m2, inclusive
• Fibre intake below recommended limits as assessed by dietary fibre intake short food frequency questionnaire (DFI-FFQ) (16).
• Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

You may not qualify if:

• Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
• Chronic diseases that can affect study parameters, including but not limited to metabolic syndrome, chronic obstructive pulmonary disease, diabetes mellitus, auto-immune disease, cardiovascular disease, cerebrovascular disease, gastrointestinal disease or history of abdominal surgery with removal of (part of) small or large intestine, or any known condition that can interfere with treatment compliance such as psychiatric disease or drug dependence.
• Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
• Systolic blood pressure (SBP) greater than 180 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 120 or less than 50 mm Hg at screening.
• Abnormal findings in the resting ECG at screening defined as:
• QTcF\> 450 for males or QTcF\>470 for females or QTcF \< 300 ms;
• Personal or family history of congenital long QT syndrome or sudden death;
• Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or history of cardiac pacemaker.
• Use of antibiotics, antacids, laxatives, statins, anti-diarrheal, immunomodulatory or antidiabetic medication \<3 months before start of study.
• Use of any medication or vitamin, mineral, herbal, and dietary supplements within 7 days of study product administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator.
• Vegan, macrobiotic, slimming or medically prescribed diet up to 3 months prior to the first administration.
• History of food allergies or intolerances or any confirmed significant allergic reactions (urticarial or anaphylaxis) against any drug or multiple documented drug allergies.
• Participation in an investigational drug or device study within 3 months prior to first dosing.
• History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent, or positive test for drugs of abuse at screening or pre-dose.
• Active smoker up to 15 years prior to the screening visit.

Sponsors & Collaborators

• Centre for Human Drug Research, Netherlands: lead
• Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek (TNO): collaborator

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333CL, Netherlands

Location

Related Publications (1)

• Eveleens Maarse BC, Eggink HM, Warnke I, Bijlsma S, van den Broek TJ, Oosterman JE, Caspers MPM, Sybesma W, Gal P, van Kraaij SJW, Schuren FHJ, Moerland M, Hoevenaars FPM. Impact of fibre supplementation on microbiome and resilience in healthy participants: A randomized, placebo-controlled clinical trial. Nutr Metab Cardiovasc Dis. 2024 Jun;34(6):1416-1426. doi: 10.1016/j.numecd.2024.01.028. Epub 2024 Feb 6.

  PMID: 38499450 DERIVED

Study Officials

• M. Moerland, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo or intervention, wash-out, intervention or placebo

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: April 2, 2021
• Study Start: December 23, 2019
• Primary Completion: July 4, 2021
• Study Completion: July 4, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)