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

NCT05747560 | Unknown

• 1 other identifier: Feng8898
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.Throughout the trial, subjects were asked to keep their usual lifestyle, food, and physical exercise and not took any dietary supplements.

Conditions

Body Height; Child, Only

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline skeletal age at 6 months

  Baseline (Day 0), Intervention end point (Day 180)

• Change from baseline body weight at 6 months

  Baseline (Day 0), Intervention end point (Day 180)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Astragalus extract

ACTIVE COMPARATOR

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

Wolfiporia extract

EXPERIMENTAL

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

Interventions

Buckwheat DIETARY_SUPPLEMENT

Take buckwheat at a dose of 500 mg twice a day for 6 months.

Placebo

Astragalus extract DIETARY_SUPPLEMENT

Take astragalus extract at a dose of 450 mg twice a day for 6 months.

Astragalus extract

Wolfiporia extract DIETARY_SUPPLEMENT

Take wolfiporia extract product at a dose of 15 g twice a day for 6 months.

Wolfiporia extract

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Treated with growth hormone;
• Sexual precocity;
• Abnormal liver and kidney function;
• IGF levels: below -2SD and above +2SD;
• IGF BP3 level: below -2SD;
• Growth hormone deficiency;
• Diagnosed genetic disease;
• BMI: Underweight or obese;
• Abnormal thyroid function.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

College of Biosystems Engineering and Food Science

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Huang Qi

Study Officials

• Fengqin Feng

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Fengqin Feng, Dr

CONTACT

+8613906504026; feng_fengqin@hotmail.com

Qianqian Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Feng

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 28, 2023
• Study Start: June 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CN (1)