Clinical trial NCT04651023: Shanghai Meiji Health Science and Technology Co., Ltd
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Over Weight People
Lead sponsor: Shanghai Meiji Health Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 95
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23\<BMI\<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of 23-30 kg/m2
* Has no history of using any antidiabetic medication
* Absence of liver, kidney, or heart disease
* Absence of food allergy and daily tea consumption \<2 L
* Meet all of the above criteria and to follow the instructions given during the study.

Exclusion Criteria:

* Testing delayed for \>1 week without justification
* Difficulty attending the hospital on the required days
* Lack of data regarding the times of beverage consumption for over 5% of the study
* Abnormal overeating
* Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
* Difficulty drawing blood
* Poor confidence in the test data

Primary outcomes:
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in anthropometrix indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes in fasting biochemical indices during the study
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
Study officials:
References: