Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547801
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HMO-RCT
Brief Summary:
A randomized double-blind placebo-controlled parallel arm study of 2-fucosyllactose 2-FL was conducted in healthy males and females between the ages of 18 and 65 at the time of consent 2-FL is one of the most prominent HMOs in human milk Preclinical studies indicate that 2-FL feeding is prebiotic anti-inflammatory anti-thrombotic and may reduce skeletal muscle atrophy during energy restriction The investigators hypothesize that supplementation of 2-FL affects the preservation of muscle mass strength and markers of health during exercise and a hypo-energetic weight loss program To test this hypothesis the investigators will compare 3 gday of 2-FL with 3 gday of maltodextrin placebo as a daily supplement
Detailed Description:
Objective To investigate the effects of daily supplementation with 3 gday of 2-fucosyllactose 2-FL compared to 3 gday of maltodextrin placebo on muscle mass preservation strength and health markers during exercise and a hypo-energetic weight loss program in healthy adults
Study Design This study will be a randomized double-blind placebo-controlled parallel arm trial
Participants Participants will include healthy males and females aged 18 to 65 years at the time of consent with a BMI between 25 to 40 kgm² andor body fat greater than 30 Preference will be given to individuals with a BMI between 25 to 32 kgm² who express a desire to lose weight and participate in a fitness exercise program
Intervention Participants will be randomly assigned to receive either 3 gday of 2-FL or 3 gday of maltodextrin placebo administered daily for the duration of the study
Ethical Considerations This study will adhere to ethical guidelines for human research ensuring participant confidentiality informed consent and data protection
Timeline The study will commence upon institutional approval and is expected to be completed within 12 weeks
This study aims to provide insights into the potential benefits of 2-FL supplementation on muscle preservation strength and overall health during exercise and weight loss efforts contributing to the understanding of its role as a dietary supplement
Study Design This study will be a randomized double-blind placebo-controlled parallel arm trial
Participants Participants will include healthy males and females aged 18 to 65 years at the time of consent with a BMI between 25 to 40 kgm² andor body fat greater than 30 Preference will be given to individuals with a BMI between 25 to 32 kgm² who express a desire to lose weight and participate in a fitness exercise program
Intervention Participants will be randomly assigned to receive either 3 gday of 2-FL or 3 gday of maltodextrin placebo administered daily for the duration of the study
Ethical Considerations This study will adhere to ethical guidelines for human research ensuring participant confidentiality informed consent and data protection
Timeline The study will commence upon institutional approval and is expected to be completed within 12 weeks
This study aims to provide insights into the potential benefits of 2-FL supplementation on muscle preservation strength and overall health during exercise and weight loss efforts contributing to the understanding of its role as a dietary supplement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None