Last updated: September 27, 2021
Sponsor: UAS Labs LLC
Overall Status: Completed
Phase
N/A
Condition
Obesity
Hypertriglyceridemia
Weight Loss
Treatment
N/AClinical Study ID
NCT04260997
AFCRO-112
Ages 25-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent;
- Aged between 25 and 65 years inclusive;
- Body mass index between 25.0 to 29.9 Kg/m2, inclusive;
- Waist-hip ratio of ≥0.91 for males and ≥0.81 for females;
- Sedentary lifestyle, exercising ≤2 times/week;
- Good general health, as determined by the investigator;
- Willing to consume the investigational product daily for the duration of the study;
- Outside the healthy parameters of visceral adipose tissue, defined as 762 cm3 formales and 256 cm3 for females.
Exclusion
Exclusion Criteria:
- Females who are pregnant, lactating or wish to become pregnant during the study;
- Participant regularly takes probiotic supplements, or has within the 4-weeks prior torandomisation or plans to during the study;
- Participant is hypersensitive to any of the components of the investigational product;
- Participant is severely immuno-compromised (HIV positive, transplant patient, onantirejection medications, on a steroid for >30 days, or has underwent chemotherapy orradiotherapy within the last year);
- Participant has Type 1 or Type 2 Diabetes Mellitus;
- Participant has a history of bariatric surgery;
- Participant has taken anti-obesity medication or supplements in the 12-weeks prior torandomisation or plans to during the study;
- Participant is actively or has recently (3 months prior to randomisation) participatedin a weight loss program or weight change of 3 kg during the past 3 months;
- Participant has a life-threatening illness;
- Participant is on a glucose lowering medication, anti-psychotic drugs or anymedication that the investigator determines could impact the results of the study;participant has commenced use, within 3-months of randomisation, anti-hypertensivedrugs, anti-depressive drugs, statin or any other medication that the investigatordetermines could impact the results of the study;
- Participant 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;
- Participant has a recent history of drug and/or alcohol abuse at the time ofenrolment;
- Participant is currently, or planning to participate in another study during the studyperiod;
- Participant has a history of non-compliance;
- Participant has taken antibiotics in the 12-weeks prior to randomisation.
Study Design
Total Participants: 125
Study Start date:
July 01, 2020
Estimated Completion Date:
September 01, 2021
Connect with a study center
Atlantia Food Clinical Trials
Cork,
IrelandSite Not Available
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