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Completed

NCT Number: NCT05448274

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

About this study

By analyzing blood samples, indirect calorimetric as well as thermographic assessment of clavicular temperature we want to investigate whether or not the commensal gut bacterium Ruminococcus toqrues strain ATCC 27756 has any metabolic effects in healthy adults. The subjects will recieve the intervention with the live bacterium given through a duodenal feeding tube. The trial is double blinded and placebo controlled using a crossover design. Subjects will be given an intervention with either placebo or Ruminococcus on two different study days with up to six weeks of wash-out between each study day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Biological

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

Ruminococcus torques

Biological

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

Primary outcomes

  1. Matsuda Insulin Sensitivity Index

    Time frame: 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)

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

Secondary outcomes

  1. Ruminococcus Irisin-Like Peptide (RUCILP)

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

    Differences in plasma RUCILP concentration between the two study days

  2. Peptide YY

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

    Differences in plasma Peptide YY concentration between the two study days

  3. Glucose profile

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

    Difference in blood glucose profile during the entirety of the study day

  4. Resting energy expenditure

    Time frame: Three times during the study day for 15 minutes

    Difference in resting energy expenditure measured by indirect calorimetric

  5. Activation of brown adipose tissue

    Time frame: 15 minutes 3 times during each study day

    Difference in temperature measured with thermographic camera of the collar bones

  6. Bone dynamics

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

    Differences in measures of biomarkers of bone turnover in blood

  7. Gut microbiota

    Time frame: Samples taken prior to each visit (experimental days and follow-up visits)

    Changes in gut microbiota composition after each intervention

  8. Metabolome

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

    Changes is plasma metabolome after intervention

  9. Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1

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

    Differences in area under the curve between the two study days

  10. Cytokine profile

    Time frame: During the six hours of the study day

    Differences in the cytokine profiles during the study day

Other outcomes

  1. Heart rate

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

    Changes in heart rate during study day

  2. Blood pressure

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

    Changes in blood pressure during study day

  3. Various hormones related to metabolism

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

    Differences in measures of various hormones during the study day

  4. Standard hematologic blood samples

    Time frame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day

    Differences in measures of standard hematologic biomarkers in the blood, such as platelets

  5. Standard clinical biochemical variables

    Time frame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day

    Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine

Sponsors and collaborators

Lead sponsor

Oluf Pedersen

Other

Collaborators

  • Technical University of Denmark
  • University Hospital, Gentofte, Copenhagen
  • University of Copenhagen

Registry information

Official study title

An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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