ObesityNCT04042181
The Effects of Supplementation of a Probiotic, B. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.
A study testing Bifidobacterium longum in people with Obesity, run by University College Cork at 1 site in Ireland.
Trial summary
Obesity levels worldwide have tripled since the mid 1070's. Obesity and its co-morbidities, metabolic syndrome, type II diabetes, and cardiovascular disease, are serious widespread health concerns which urgently need to be addressed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bifidobacterium longum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jul 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Give written informed consent;
- Be between 18 and 65 years of age;
- Has a BMI of between 28.0 - 34.9 Kg/m2;
- Have a waist-hip ratio of ≥0.88 for males and ≥0.83 for females
- Is in general good health, as determined by the investigator;
- Willing to consume the investigational product daily for the duration of the study.
Who cannot join
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
- Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
- Subject regularly takes probiotics;
- Subject is hypersensitive to any of the components of the test product;
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- Subject is severely immuno-compromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or underwent chemotherapy or radiotherapy within the last year);
- Subject has Type 1 or Type 2 Diabetes Mellitus;
- Subject has a history of bariatric surgery;
- Subject has taken anti-obesity medication in the 12-weeks prior to randomisation
- Subject is actively or has recently (3 months prior to randomisation) participated in a weight loss program or weight change of 3 kg during the past 3 months
- Subject has a life-threatening illness
- Subject is on a Metaformin, anti-psychotic drugs or any medication that the investigator determines could impact the results of the study; subject has commenced use within 3-months of randomization anti-hypertensive drugs, anti-depressive drugs, statin or any other medication that the investigator determines could impact the results of the study.
- Subject has a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer) or lactose intolerance;
- Subject has a history of drug and/or alcohol abuse at the time of enrolment
- Subject is currently, or planning, to participate in another study during the study period
- Subject has a history of non-compliance
- Subjects who have been on antibiotics in the 12-weeks prior to randomisation
- Subject consumes vitamin D supplements >5000 IU/d
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Effects of 12-weeks Supplementation of a Probiotic, Bif. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.
Obesity levels worldwide have tripled since the mid 1070's. Obesity and its co-morbidities, metabolic syndrome, type II diabetes, and cardiovascular disease, are serious widespread health concerns which urgently need to be addressed. G protein-coupled receptors (GPCRs), such as the ghrelin receptor (GHS-R1a), are well known for their key role in the homeostatic control of food intake and energy balance. Ghrelin is the major hunger hormone in the body and ghrelin-receptor antagonists have been advanced as potential anti-obesity agents. This receptor is therefore an ideal target for orally delivered probiotic-derived bioactives with excellent bioavailability. Bacterial strains with the ability to modulate these receptors may have high potential as probiotics with the ability to induce appetite modulation effects.
Due to promising pre-clinical results, the investigators aim to trial a Bif Longum probiotic, which can target these receptors, in an obese human population. We hypothesise that the probiotic will positively alter the gut-brain axis, improving control of hunger and satiety signalling adults with high BMI, leading to decreased BMI and waist-hip ratio scores. Furthermore, the investigators expect that the mechanism through which the probiotic is having a positive impact can be determined via investigation of the microbiota composition, gut hormone levels and circulating immune profiles.
- Conditions
- Obesity
- Being tested
- Placebo, Bifidobacterium longum
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
standard food grade excipients
Bifidobacterium longumDietary supplement
Target dose of 1x10^10 CFU/day, plus standard food grade excipients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Bifidobacterium longum | Active comparator | Not described Receives: Dietary Supplement: Bifidobacterium longum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI measurement
Significant change from week-zero to week-12 between active and placebo groups in percentage increase/decrease BMI
Measured: From week-zero to week 12
Secondary outcomes (8)
Change in Waist:Hip ratio
Significant changes from week-zero to week 6 and 12 between active and placebo groups in waist:hip ratio
Measured: Significant changes from week-zero to week 6 and 12
Change in serum insulin concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in serum insulin concentration
Measured: Significant changes from week-zero to week 6 and 12
Change in plasma HbA1c concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma HbA1c concentration
Measured: Significant changes from week-zero to week 6 and 12
Change in plasma glucose concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma glucose concentration
Measured: Significant changes from week-zero to week 6 and 12
Change in peripheral blood total cholesterol
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood total cholesterol
Measured: Significant changes from week-zero to week 6 and 12
Change in peripheral blood triglycerides
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood total triglycerides
Measured: Significant changes from week-zero to week 6 and 12
Change in peripheral blood HDL
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood HDL
Measured: Significant changes from week-zero to week 6 and 12
Change in peripheral blood direct LDL
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood direct LDL
Measured: Significant changes from week-zero to week 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start9 Jul 2018
- Primary completion21 Dec 2018
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Atlantia Food Clinical Trials, CREMO SA
- Responsible party
- Principal investigator, Prof Ted Dinan, University College Cork
- Investigators
- Ted Dinan, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042181
- Sponsor's protocol ID
- AFCRO-088
- Status last verified
- Jul 2019
- First submitted
- 20 Nov 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Effects of 12-weeks Supplementation of a Probiotic, Bif. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.
- ClinicalTrials.gov ID
- NCT04042181
- Acronym / sponsor ID
- AFCRO-088
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Atlantia Food Clinical Trials, CREMO SA
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity levels worldwide have tripled since the mid 1070's. Obesity and its co-morbidities, metabolic syndrome, type II diabetes, and cardiovascular disease, are serious widespread health concerns which urgently need to be addressed. G protein-coupled receptors (GPCRs), such as the ghrelin receptor (GHS-R1a), are well known for their key role in the homeostatic control of food intake and energy balance. Ghrelin is the major hunger hormone in the body and ghrelin-receptor antagonists have been advanced as potential anti-obesity agents. This receptor is therefore an ideal target for orally delivered probiotic-derived bioactives with excellent bioavailability. Bacterial strains with the ability to modulate these receptors may have high potential as probiotics with the ability to induce appetite modulation effects.
Due to promising pre-clinical results, the investigators aim to trial a Bif Longum probiotic, which can target these receptors, in an obese human population. We hypothesise that the probiotic will positively alter the gut-brain axis, improving control of hunger and satiety signalling adults with high BMI, leading to decreased BMI and waist-hip ratio scores. Furthermore, the investigators expect that the mechanism through which the probiotic is having a positive impact can be determined via investigation of the microbiota composition, gut hormone levels and circulating immune profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Bifidobacterium longum | Active comparator | Dietary Supplement: Bifidobacterium longum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Give written informed consent;
- Be between 18 and 65 years of age;
- Has a BMI of between 28.0 - 34.9 Kg/m2;
- Have a waist-hip ratio of ≥0.88 for males and ≥0.83 for females
- Is in general good health, as determined by the investigator;
Key exclusion criteria (19 listed)
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- Subject regularly takes probiotics;
- Subject is hypersensitive to any of the components of the test product;
- Subject is severely immuno-compromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or underwent chemotherapy or radiotherapy within the last year);
- Subject has Type 1 or Type 2 Diabetes Mellitus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebostandard food grade excipients | Dietary supplement | Placebo |
| Bifidobacterium longumTarget dose of 1x10^10 CFU/day, plus standard food grade excipients | Dietary supplement | Bifidobacterium longum |
Primary outcome
Change in BMI measurement
Time frame: From week-zero to week 12
Significant change from week-zero to week-12 between active and placebo groups in percentage increase/decrease BMI
8 secondary outcomes
Change in Waist:Hip ratio
Time frame: Significant changes from week-zero to week 6 and 12
Change in serum insulin concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in plasma HbA1c concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in plasma glucose concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood total cholesterol
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood triglycerides
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood HDL
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood direct LDL
Time frame: Significant changes from week-zero to week 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Dinan principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum in people with Obesity, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI measurement (time frame: From week-zero to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.