The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.

NCT05448274 | Completed

• 1 other identifier: H-21075670
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

Conditions

Overweight; Healthy

Keywords

Metabolism; Microbiota; Ruminococcus torques

Outcome Measures

Primary Outcomes (1)

• Matsuda Insulin Sensitivity Index

  Differences in calculated Matsuda Insulin Sensitivity Index between the two study days

  During two hours following a standard glucose solution (75g glucose in 250 ml of water) after the second dose of Ruminococcus or placebo has been given during the study day (second measurement up to six weeks later)

Secondary Outcomes (10)

• Ruminococcus Irisin-Like Peptide (RUCILP)

  During the six hours of the study day (up to six weeks between study days)

• Peptide YY

  During the six hours of the study day (up to six weeks between study days)

• Glucose profile

  During the six hours of the study day (up to six weeks between study days)

• Resting energy expenditure

  Three times during the study day for 15 minutes

• Activation of brown adipose tissue

  15 minutes 3 times during each study day

Other Outcomes (5)

• Heart rate

  During the six hours of the study day (up to six weeks between study days)

• Blood pressure

  During the six hours of the study day (up to six weeks between study days)

• Various hormones related to metabolism

  During the six hours of the study day (up to six weeks between study days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Biological: Placebo

Ruminococcus torques

EXPERIMENTAL

10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Biological: Ruminococcus torques

Interventions

Placebo BIOLOGICAL

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Placebo

Ruminococcus torques BIOLOGICAL

10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Ruminococcus torques

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years
• Self-reported good health
• Caucasian
• Body Mass Index \> 27 kg/m\^2

You may not qualify if:

• Any known disorder/disease that could interfere with study results or is seen as compromising to the study (as assessed by the investigator), for example diabetes, cancer or cardiovascular or kidney disease.
• Use of any daily medication as well as p.r.n. (pro re nata; not taken regularly) medication that cannot be discontinued during the trial
• Use of antibiotics during the recent three months
• Acute or chronic gastrointestinal symptoms
• Lactose intolerance
• Pregnancy - ongoing or planned
• Smoking
• Alcohol or drug abuse
• Use of creatine as dietary supplement during study period
• Plasma creatinine above the normal range (\>105 μmol/L for men and \>90 μmol/L for women)
• Known significant liver disease or plasma alanine transaminase concentration ≥ 3 × normal value
• Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges

Sponsors & Collaborators

• Oluf Pedersen: lead
• University of Copenhagen: collaborator
• Technical University of Denmark: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oluf B Pedersen, Prof, MD

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Model Details: A crossover study where subjects recieve placebo or Ruminococcus torques on two different study days with three to six weeks of wash-out between the study days.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: May 3, 2023
• Primary Completion: September 6, 2023
• Study Completion: September 14, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)