Osteoporosis, OsteopeniaNCT04748250
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
A study testing Acupuncture needles and Soy phytoestrogens in people with Osteoporosis, Osteopenia, run by Hend Reda Sakr at 1 site in Egypt.
Trial summary
The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that: There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Acupuncture needles and Soy phytoestrogens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to 20 Feb 2021
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All girls diagnosed with female athlete triad resulting in osteopenia
- Their age between 14-18 years old
- Their body mass index is less than 5 percent according to the gross motor chart
- All participants are gymnastics players
- All are medically stable
- They will be able to follow instructions
Who cannot join
- Marriage
- Pregnancy
- Taking any hormonal treatment
- Receiving any other form of traditional physical therapy modalities
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that:
- There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?
Read the detailed description
Many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. So that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. These types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. A limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. Study Design: A prospective, randomized, single-blind, pre-post-test, controlled trial.
Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Acupuncture needles, Soy phytoestrogens
- Keywords
- female athlete triad
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Female Athlete Triad Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
Standard acupuncture needle which is 3 cm long with diameter o.3 mm
Soy phytoestrogensDietary supplement
100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | This group will receive acupuncture therapy for 30 minutes, three times per week for six months using the internationally recognized standard acupuncture needle which is 3 cm long with diameter o.3 mm, pushing it with twisting movement to the required depth until the De Qi sensation will be obtained. Receives: Device: Acupuncture needles |
| Soy Group | Experimental | This group will receive soy products for six months which including: Soy milk: 100 millilitre of soy milk every day, every bottle of original soy milk contains 300 millilitre or Soy beans: 100 gram of cooked soy beans per day. Receives: Dietary Supplement: Soy phytoestrogens |
| Acupuncture and Soy Group | Experimental | Every patient in this group will receive acupuncture therapy sessions in abdominal acu-points as in group (A) for 30 minutes, three times per week for six months in addition to administration of soy products in the form of soy milk or soy beans daily in breakfast for three months as in group (B). Receives: Device: Acupuncture needles; Dietary Supplement: Soy phytoestrogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
DEXA(Dual-energy X-ray absorptiometry)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Jul 2020
- Primary completion10 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hend Reda Sakr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hend Reda Sakr, Badr University
- Investigators
- Hend Reda, PhD, Study director, Badr University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748250
- Sponsor's protocol ID
- Hend1
- Status last verified
- Nov 2021
- First submitted
- 4 Feb 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
- ClinicalTrials.gov ID
- NCT04748250
- Acronym / sponsor ID
- Hend1
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- female athlete triad
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hend Reda SakrUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 10 Feb 2021 (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.
The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that:
- There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?
Detailed description
Many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. So that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. These types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. A limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. Study Design: A prospective, randomized, single-blind, pre-post-test, controlled trial.
Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Device: Acupuncture needlesThis group will receive acupuncture therapy for 30 minutes, three times per week for six months using the internationally recognized standard acupuncture needle which is 3 cm long with diameter o.3 mm, pushing it with twisting movement to the required depth until the De Qi sensation will be obtained. |
| Soy Group | Experimental | Dietary Supplement: Soy phytoestrogensThis group will receive soy products for six months which including: Soy milk: 100 millilitre of soy milk every day, every bottle of original soy milk contains 300 millilitre or Soy beans: 100 gram of cooked soy beans per day. |
| Acupuncture and Soy Group | Experimental | Device: Acupuncture needles, Dietary Supplement: Soy phytoestrogensEvery patient in this group will receive acupuncture therapy sessions in abdominal acu-points as in group (A) for 30 minutes, three times per week for six months in addition to administration of soy products in the form of soy milk or soy beans daily in breakfast for three months as in group (B). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- All girls diagnosed with female athlete triad resulting in osteopenia
- Their age between 14-18 years old
- Their body mass index is less than 5 percent according to the gross motor chart
- All participants are gymnastics players
- All are medically stable
Key exclusion criteria (4 listed)
- Marriage
- Pregnancy
- Taking any hormonal treatment
- Receiving any other form of traditional physical therapy modalities
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 |
|---|---|---|
| Acupuncture needlesStandard acupuncture needle which is 3 cm long with diameter o.3 mm | Device | Acupuncture Group, Acupuncture and Soy Group |
| Soy phytoestrogens100 millilitre of soy milk every day or 100 gram of cooked soy beans per day. | Dietary supplement | Acupuncture and Soy Group, Soy Group |
Primary outcome
Bone Mineral Density
Time frame: Six months
DEXA(Dual-energy X-ray absorptiometry)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Hend Reda, PhD study director
Badr University in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles and Soy phytoestrogens in people with Osteoporosis, Osteopenia, run by Hend Reda Sakr at 1 site in Egypt.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 10 Nov 2021. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: Six months). 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 10 Nov 2021.