Body HeightNCT05747560
Study on the Effect of Dietary Supplements on Height Improvement in Children
A study testing Buckwheat, Astragalus extract and Wolfiporia extract in people with Body Height and Child, Only, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Height, Child, Only
- What is being tested?
- Buckwheat, Astragalus extract and Wolfiporia extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body height: from the 10th to the 75th;
- Skeletal age: bone age and actual age ±1.
Who cannot join
- 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;
Show all 9Show fewer
- Diagnosed genetic disease;
- BMI: Underweight or obese;
- Abnormal thyroid function.
Trial locations and contacts
1 site in 1 country.
Qianqian Wang contact
China1 site, 1 recruiting
- Recruiting
College of Biosystems Engineering and Food Science
Hangzhou, Zhejiang, 310000
Fengqin Feng, 13906504026, feng_fengqin@hotmail.com
About this study
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.
Read more
- 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.
- 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.
- 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.
- Conditions
- Body Height, Child, Only
- Being tested
- Buckwheat, Astragalus extract, Wolfiporia extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuckwheatDietary supplement
Take buckwheat at a dose of 500 mg twice a day for 6 months.
Astragalus extractDietary supplement
Take astragalus extract at a dose of 450 mg twice a day for 6 months.
Wolfiporia extractDietary supplement
Take wolfiporia extract product at a dose of 15 g twice a day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Wolfiporia extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body height at 6 months
Determination of the change of body height of the participants at 6 months.
Measured: Baseline (Day 0), Intervention end point (Day 180)
Secondary outcomes (2)
Change from baseline skeletal age at 6 months
Determination of the change of skeletal age of the participants at 6 months.
Measured: 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.
Measured: Baseline (Day 0), Intervention end point (Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start20 Jun 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body HeightStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqin Feng, Zhejiang University
- Investigators
- Fengqin Feng, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747560
- Sponsor's protocol ID
- Feng8898
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Dietary Supplements on Height Improvement in Children
- ClinicalTrials.gov ID
- NCT05747560
- Acronym / sponsor ID
- Feng8898
- Conditions
- Body Height, Child, Only
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: BuckwheatParticipants in the Placebo will consume buckwheat at a dose of 500 mg, twice a day (morning and evening) for 6 months. |
| Astragalus extract | Active comparator | Dietary Supplement: Astragalus extractParticipants in the Astragalus extract will take dietary supplement with astragalus extract at a dose of 450 mg, twice a day for the same duration. |
| Wolfiporia extract | Experimental | Dietary Supplement: Wolfiporia extractParticipants in the Wolfiporia extract will take dietary supplement with wolfiporia extract at a dose of 15 g, twice a day for the same duration. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Body height: from the 10th to the 75th;
- Skeletal age: bone age and actual age ±1.
Key exclusion criteria (9 listed)
- Treated with growth hormone;
- Sexual precocity;
- Abnormal liver and kidney function;
- IGF levels: below -2SD and above +2SD;
- IGF BP3 level: below -2SD;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuckwheatTake buckwheat at a dose of 500 mg twice a day for 6 months. | Dietary supplement | Placebo |
| Astragalus extractTake astragalus extract at a dose of 450 mg twice a day for 6 months. | Dietary supplement | Astragalus extract |
| Wolfiporia extractTake wolfiporia extract product at a dose of 15 g twice a day for 6 months. | Dietary supplement | Wolfiporia extract |
Primary outcome
Change from baseline body height at 6 months
Time frame: Baseline (Day 0), Intervention end point (Day 180)
Determination of the change of body height of the participants at 6 months.
2 secondary outcomes
Change from baseline skeletal age at 6 months
Time frame: Baseline (Day 0), Intervention end point (Day 180)
Change from baseline body weight at 6 months
Time frame: Baseline (Day 0), Intervention end point (Day 180)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianqian Wang contact
Fengqin Feng study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buckwheat, Astragalus extract and Wolfiporia extract in people with Body Height and Child, Only, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengqin Feng, Dr (+8613906504026, feng_fengqin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body height at 6 months (time frame: Baseline (Day 0), Intervention end point (Day 180)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.