Study product A (Wonderlab wonder4shape)
Dietary SupplementPartipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
NCT Number: NCT05710055
The goal of this interventional study is to evaluate the efficacy of probiotics with prebiotics on overweight.
200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months.
Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.
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Notify Me25 year–45 year
All sexes
Interventional
Not applicable
Ai'er Hospital, Shanghai, Shanghai Municipality, China
This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
Time frame: baseline day 0, day 60
Change of Weight in Kg by Inbody S10 from baseline to 2 months
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4) for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces SCFA for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Feces sIgA for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90
Liver function test for each visit interval
Shenzhen Precision Health Food Technology Co. Ltd.,
Other Gov
A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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