Status:
COMPLETED
Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
Lead Sponsor:
Advanced Protein Technologies Corporation
Conditions:
Weight Loss
Eligibility:
All Genders
18-65 years
Phase:
NA
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 i...
Detailed Description
Objective: To investigate the effects of daily supplementation with 3 g/day of 2'-fucosyllactose (2'-FL) compared to 3 g/day of maltodextrin placebo on muscle mass preservation, strength, and health m...
Eligibility Criteria
Inclusion
- Men and women the ages of 18 to 65 at the time of consent
- Ability to comply with study procedures
- Availability to complete the study based on duration of individual visits and scheduling requirements
- Body mass index (BMI) between 25 and 40 kg/m2 and/or body fat less than 30%, with a preference between a BMI of 25 - 32 kg/m2, and a desire to lose weight and participate in a fitness exercise program
Exclusion
- Pregnant, breastfeeding, or wish to become pregnant during the study
- Planning major changes in lifestyle (i.e., diet, dieting, exercise level, travel) during the study
- Recent history (\< 3 months) of exercise training or weight loss (\> 5%)
- Orthopedic limitation preventing participation in a general fitness program
- Uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder in which participation in a general fitness program is contraindicated
- Taking weight loss dietary supplements or medications during the last 4 weeks
- History within the previous 12 months of alcohol or substance abuse
- Heavy smoking (\> 1 pack/day within the past 3 months)
- Known allergy to milk, lactose, or any other milk product
Key Trial Info
Start Date :
May 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06547801
Start Date
May 4 2023
End Date
February 22 2024
Last Update
August 14 2024
Active Locations (1)
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1
Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station
College Station, Texas, United States, 77843