Study on the Effect of Dietary Supplements on Height Improvement in Children

With the increasing improvement of living standard, more and more people are concerned about the body height of their children. It has been reported that 542 out of 1000 children (54.2%) failed to meet the standards of height. Moreover, nearly 80% was disappointed with the height of their children. The body height of child is mainly influenced by 60% of genetic factors (6 out of 10) and 40% of acquired factors which includes nutrition, exercise, sleep, psychology, disease and so on. Therefore, it is an important way to solve the problem by regulating the acquired factors. At present, inject growth hormone (GH) for children is the main way to solve the problem of children's body weight. However, high price, complex operation skills, and side effects limits the implication of GH. Additionally, the effect of traditional Chinese medicine therapy, exercise therapy, and dietary supplement are of dubious benefit and without clinical support. Elevated insulin like growth factor-1 (IGF-1) levels in the human body have been recognized as one of the core criteria for evaluating body enhancement therapy. Currently, there is no dietary supplement intervention to enhance the sensitivity of GH receptor and IGF-1 receptor. The goal of this clinical trial is to test the effect of dietary supplements on height improvement in children (aged 8-15 years of both genders). The main question it aims to answer is: Study the effect of dietary supplements (a formula based on enhancing the sensitivity of GH receptor and IGF-1 receptor) on height improvement in children by.

Participants will be randomly divided into three groups: Placebo, Astragalus extract, and Wolfiporia extract.

1. Participants in the Placebo will consume placebo (a look-alike substances that contains no active drug) at a dose of 500 mg, twice a day (morning and evening) for 6 months. Participants in the Astragalus extract will take dietary supplement with astragalus extract at a dose of 450 mg, twice a day for the same duration. Participants in the Wolfiporia extract will take dietary supplement with wolfiporia extract at a dose of 15 g, twice a day for the same duration.
2. Taken blood sample at the timepoint of baseline (Day 0), intermediate point (Day 90), intervention end point (Day 180)) to detect biochemical markers, as well as body height and weight, and skeletal age.
3. Throughout the trial, subjects were asked to keep their usual lifestyle, food, and physical exercise and not took any dietary supplements.

Researchers will compare the effects of Placebo with Astragalus extract, placebo with Wolfiporia extract, and Astragalus extract with Wolfiporia extract to see if Astragalus extract and Wolfiporia extract increase children's height, and whether Astragalus extract or Wolfiporia extract is more works well.

Study Overview

• Status: Recruiting
• Conditions: Child, Only; Body Height
• Intervention / Treatment: Dietary supplement: Buckwheat; Dietary supplement: Astragalus extract; Dietary supplement: Wolfiporia extract

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fengqin Feng, Dr; Phone Number: +8613906504026; Email: feng_fengqin@hotmail.com
• Study Contact Backup: Name: Qianqian Wang

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • College of Biosystems Engineering and Food Science
      • Contact: Fengqin Feng; Phone Number: 13906504026; Email: feng_fengqin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Body height: from the 10th to the 75th;
2. Skeletal age: bone age and actual age ±1.

Exclusion Criteria:

1. Treated with growth hormone;
2. Sexual precocity;
3. Abnormal liver and kidney function;
4. IGF levels: below -2SD and above +2SD;
5. IGF BP3 level: below -2SD;
6. Growth hormone deficiency;
7. Diagnosed genetic disease;
8. BMI: Underweight or obese;
9. Abnormal thyroid function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants in the Placebo will consume buckwheat at a dose of 500 mg, twice a day (morning and evening) for 6 months.	Dietary supplement: Buckwheat; Take buckwheat at a dose of 500 mg twice a day for 6 months.
Active Comparator: Astragalus extract; Participants in the Astragalus extract will take dietary supplement with astragalus extract at a dose of 450 mg, twice a day for the same duration.	Dietary supplement: Astragalus extract; Take astragalus extract at a dose of 450 mg twice a day for 6 months.
Experimental: Wolfiporia extract; Participants in the Wolfiporia extract will take dietary supplement with wolfiporia extract at a dose of 15 g, twice a day for the same duration.	Dietary supplement: Wolfiporia extract; Take wolfiporia extract product at a dose of 15 g twice a day for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline body height at 6 months	Determination of the change of body height of the participants at 6 months.	Baseline (Day 0), Intervention end point (Day 180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline skeletal age at 6 months	Determination of the change of skeletal age of the participants at 6 months.	Baseline (Day 0), Intervention end point (Day 180)
Change from baseline body weight at 6 months	Determination of the change of body weight of the participants at 6 months.	Baseline (Day 0), Intervention end point (Day 180)

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Study Chair: Fengqin Feng, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2023
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Feng8898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No