Weight LossNCT04834180
Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
A study testing Hypocaloric diet plan, Auricular Acupuncture and Acupressure in people with Weight Loss and Abdominal Obesity, run by Andreia Vieira.
Trial summary
The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Abdominal Obesity
- What is being tested?
- Hypocaloric diet plan, Auricular Acupuncture and Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 15 Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Unfamiliar to acupuncture
Who cannot join
- Psychotropic medication
- Psychiatric or thyroid disorders
- Pregnancy
About this study
The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.
Read the detailed description
Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).
- Conditions
- Weight Loss, Abdominal Obesity
- Being tested
- Hypocaloric diet plan, Auricular Acupuncture, Acupressure
- Medical subject headings
- Weight Loss, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric diet planDietary supplement
The hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss.
Auricular AcupunctureOther
Also called Auriculotherapy
Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.
AcupressureOther
Also called Auriculotherapy
Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.
| Study group | Role | What they receive |
|---|---|---|
| Vaccaria seeds plus diet therapy | Sham comparator | Vaccaria seeds at the exterior side of the ear area, standard points were selected according to clinical experience in traditional Chinese medicine: Shenmen (TF4), Stomach (CO4), Hunger, Mouth (CO1), Point Zero HX1) and Sanjiao (CO17). Mustard seeds (Vaccaria ear seeds, Beijing Zhongyan Taihe Medicine, Beijing, China) were used, plus diet therapy prescribed by a licensed nutritionist. Receives: Dietary Supplement: Hypocaloric diet plan; Other: Acupressure |
| ASP needles plus diet therapy | Active comparator | ASP needles on the outside of the ear standard points were selected according to clinical experience in traditional Chinese medicine: ASP gold needles, strengthening the centre with point 0 (the umbilicus) in the dominant ear, Porta Fortunae in the non-dominant ear, Barbiturate in the non-dominant ear, Psychosomatique key point in the dominant ear and the point Aggression, plus diet therapy prescribed by a licensed nutritionist. Receives: Dietary Supplement: Hypocaloric diet plan; Other: Auricular Acupuncture |
| only diet therapy | No intervention | only diet therapy prescribed by a licensed nutritionist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
TANITA® bio-impedance scale (model 762)
Measured: 1 month
Waist Perimeter (cm)
tape measure from SECA® (model 203)
Measured: 1 month
height (cm)
SECA® stadiometer (model 208)
Measured: 1 month
body fat (%)
TANITA® bio-impedance scale (model 762)
Measured: 1 month
Body mass index (kg/m2)
Body mass index is defined as the body mass divided by the square of the body height.
Measured: 1 month
Waist-to-height ratio (cm2)
The WHTR was obtained by dividing the waist circumference (cm) by height (cm).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2015
- Primary completion1 Sep 2015
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreia Vieira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreia Vieira, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834180
- Sponsor's protocol ID
- uportoweightloss
- Other IDs
- uportoweightloss
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
- ClinicalTrials.gov ID
- NCT04834180
- Acronym / sponsor ID
- uportoweightloss
- Conditions
- Weight Loss, Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Andreia VieiraUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 8 Apr 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 implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.
Detailed description
Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccaria seeds plus diet therapy | Sham comparator | Dietary Supplement: Hypocaloric diet plan, Other: AcupressureVaccaria seeds at the exterior side of the ear area, standard points were selected according to clinical experience in traditional Chinese medicine: Shenmen (TF4), Stomach (CO4), Hunger, Mouth (CO1), Point Zero HX1) and Sanjiao (CO17). Mustard seeds (Vaccaria ear seeds, Beijing Zhongyan Taihe Medicine, Beijing, China) were used, plus diet therapy prescribed by a licensed nutritionist. |
| ASP needles plus diet therapy | Active comparator | Dietary Supplement: Hypocaloric diet plan, Other: Auricular AcupunctureASP needles on the outside of the ear standard points were selected according to clinical experience in traditional Chinese medicine: ASP gold needles, strengthening the centre with point 0 (the umbilicus) in the dominant ear, Porta Fortunae in the non-dominant ear, Barbiturate in the non-dominant ear, Psychosomatique key point in the dominant ear and the point Aggression, plus diet therapy prescribed by a licensed nutritionist. |
| only diet therapy | No intervention | –only diet therapy prescribed by a licensed nutritionist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults
- Unfamiliar to acupuncture
Key exclusion criteria (3 listed)
- Psychotropic medication
- Psychiatric or thyroid disorders
- Pregnancy
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 |
|---|---|---|
| Hypocaloric diet planThe hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss. | Dietary supplement | ASP needles plus diet therapy, Vaccaria seeds plus diet therapy |
| Auricular AcupunctureAlso: AuriculotherapyAuriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region. | Other | ASP needles plus diet therapy |
| AcupressureAlso: AuriculotherapyAuriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region. | Other | Vaccaria seeds plus diet therapy |
Primary outcome
Weight (kg)
Time frame: 1 month
TANITA® bio-impedance scale (model 762)
Waist Perimeter (cm)
Time frame: 1 month
tape measure from SECA® (model 203)
height (cm)
Time frame: 1 month
SECA® stadiometer (model 208)
body fat (%)
Time frame: 1 month
TANITA® bio-impedance scale (model 762)
Body mass index (kg/m2)
Time frame: 1 month
Body mass index is defined as the body mass divided by the square of the body height.
Waist-to-height ratio (cm2)
Time frame: 1 month
The WHTR was obtained by dividing the waist circumference (cm) by height (cm).
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 8 Apr 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric diet plan, Auricular Acupuncture and Acupressure in people with Weight Loss and Abdominal Obesity, run by Andreia Vieira.
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 3 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Weight (kg) (time frame: 1 month). The study lists 6 primary outcomes in all. 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 8 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.