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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448274
• Other study ID #: H-21075670
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: September 14, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 14, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Biological:
• Placebo
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
• Ruminococcus torques
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (4)

Lead Sponsor	Collaborator
Oluf Pedersen	Technical University of Denmark, University Hospital, Gentofte, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Changes in heart rate during study day	During the six hours of the study day (up to six weeks between study days)
Other	Blood pressure	Changes in blood pressure during study day	During the six hours of the study day (up to six weeks between study days)
Other	Various hormones related to metabolism	Differences in measures of various hormones during the study day	During the six hours of the study day (up to six weeks between study days)
Other	Standard hematologic blood samples	Differences in measures of standard hematologic biomarkers in the blood, such as platelets	During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Other	Standard clinical biochemical variables	Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine	During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Primary	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	Ruminococcus Irisin-Like Peptide (RUCILP)	Differences in plasma RUCILP concentration between the two study days	During the six hours of the study day (up to six weeks between study days)
Secondary	Peptide YY	Differences in plasma Peptide YY concentration between the two study days	During the six hours of the study day (up to six weeks between study days)
Secondary	Glucose profile	Difference in blood glucose profile during the entirety of the study day	During the six hours of the study day (up to six weeks between study days)
Secondary	Resting energy expenditure	Difference in resting energy expenditure measured by indirect calorimetric	Three times during the study day for 15 minutes
Secondary	Activation of brown adipose tissue	Difference in temperature measured with thermographic camera of the collar bones	15 minutes 3 times during each study day
Secondary	Bone dynamics	Differences in measures of biomarkers of bone turnover in blood	During the six hours of the study day (up to six weeks between study days)
Secondary	Gut microbiota	Changes in gut microbiota composition after each intervention	Samples taken prior to each visit (experimental days and follow-up visits)
Secondary	Metabolome	Changes is plasma metabolome after intervention	During the six hours of the study day (up to six weeks between study days)
Secondary	Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1	Differences in area under the curve between the two study days	During the six hours of the study day (up to six weeks between study days)
Secondary	Cytokine profile	Differences in the cytokine profiles during the study day	During the six hours of the study day