The Effects of Supplementation of a Probiotic, B. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04042181
• Other study ID #: AFCRO-088
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2019
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: December 30, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Give written informed consent;

2. Be between 18 and 65 years of age;

3. Has a BMI of between 28.0 - 34.9 Kg/m2;

4. Have a waist-hip ratio of =0.88 for males and =0.83 for females

5. Is in general good health, as determined by the investigator;

6. Willing to consume the investigational product daily for the duration of the study.

Exclusion Criteria:

1. 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).

v. 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.

2. Subject regularly takes probiotics;

3. Subject is hypersensitive to any of the components of the test product;

4. 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);

5. Subject has Type 1 or Type 2 Diabetes Mellitus;

6. Subject has a history of bariatric surgery;

7. Subject has taken anti-obesity medication in the 12-weeks prior to randomisation

8. 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

9. Subject has a life-threatening illness

10. 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.

11. 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;

12. Subject has a history of drug and/or alcohol abuse at the time of enrolment

13. Subject is currently, or planning, to participate in another study during the study period

14. Subject has a history of non-compliance

15. Subjects who have been on antibiotics in the 12-weeks prior to randomisation

16. Subject consumes vitamin D supplements >5000 IU/d

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Placebo
standard food grade excipients
• Bifidobacterium longum
Target dose of 1x10^10 CFU/day, plus standard food grade excipients

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (3)

Lead Sponsor	Collaborator
University College Cork	Atlantia Food Clinical Trials, CREMO SA

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI measurement	Significant change from week-zero to week-12 between active and placebo groups in percentage increase/decrease BMI	From week-zero to week 12
Secondary	Change in Waist:Hip ratio	Significant changes from week-zero to week 6 and 12 between active and placebo groups in waist:hip ratio	Significant changes from week-zero to week 6 and 12
Secondary	Change in serum insulin concentration	Significant changes from week-zero to week 6 and 12 between active and placebo groups in serum insulin concentration	Significant changes from week-zero to week 6 and 12
Secondary	Change in plasma HbA1c concentration	Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma HbA1c concentration	Significant changes from week-zero to week 6 and 12
Secondary	Change in plasma glucose concentration	Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma glucose concentration	Significant changes from week-zero to week 6 and 12
Secondary	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	Significant changes from week-zero to week 6 and 12
Secondary	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	Significant changes from week-zero to week 6 and 12
Secondary	Change in peripheral blood HDL	Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood HDL	Significant changes from week-zero to week 6 and 12
Secondary	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	Significant changes from week-zero to week 6 and 12