Shanghai Meiji Health Science and Technology Co., Ltd

Meiji Seika Pharma

Status: Completed

Conditions: Over Weight People

Treatments: Dietary Supplement: Nelumbo nucifera Leaf Extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT04651023

ShanghaiMHST

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

95 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (0g NnEx) per day with or after meals.

Treatment:

Dietary Supplement: Nelumbo nucifera Leaf Extract

low concentration of NnEx group

Experimental group

Description:

During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (1g NnEx) per day with or after meals.

Treatment:

Dietary Supplement: Nelumbo nucifera Leaf Extract

high concentration of NnEx group

Experimental group

Description:

During the 12-week study period, the participants consumed two bottles (2 \*200 mL) of the experimental beverage (2g NnEx) per day with or after meals.

Treatment:

Dietary Supplement: Nelumbo nucifera Leaf Extract