OverweightNCT05758363
Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
A study testing Consumption of dietary supplement. in people with Overweight, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Consumption of dietary supplement.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2023to 30 Nov 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (age: 30 - 70 YO)
- BMI over 25 kg/m2.
- Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.
Who cannot join
- Subjects with eating disorders.
- BMI less than 25 Kg/m2.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study.
- Unwillingness or inability to comply with clinical trial procedures.
- Pregnant woman.
- Participants with an active daily exercise activity.
- Subjects whose condition makes them ineligible for the study at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.
Read the detailed description
The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
- Conditions
- Overweight
- Being tested
- Consumption of dietary supplement., Consumption of control product
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of dietary supplement.Dietary supplement
Consumption of a dietary supplement rich in glutathione, selenium, zinc, vitamin D and EPA/DHA. 1 capsule per day of the dietary supplement with breakfast.
Consumption of control productOther
Consumption of 1 capsule per day of control product of identical appearance with breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Consumption of dietary supplement capsules for 6 months. Receives: Dietary Supplement: Consumption of dietary supplement. |
| Control Group | Placebo comparator | Identically appearing placebo capsules consumed for 6 months. Receives: Other: Consumption of control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of weight loss
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.
Measured: From baseline to 6 months later
Secondary outcomes (6)
Quality of life by WHOQOL-BREF
World Health Organization Quality of Life Brief version test. The raw scores are transformed into a normalized scale ranging from 4 to 20 and from 0 to 100. Higher scores indicating better quality of life.
Measured: From baseline to 6 months later
Quality of life by SF-36
Short Form 36 Health Survey Questionnaire (SF-36). The SF-36 contains 36 items that measure eight dimensions or scales. The scores for each dimension will be calculated in both raw and transformed form as indicated in the manual, with higher scores indicating better health status for that particular dimension.
Measured: From baseline to 6 months later
Depression
Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.
Measured: From baseline to 6 months later
Stress
Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).
Measured: From baseline to 6 months later
Anxiety
State-Trait Anxiety Inventory (STAI) Test. Scores can vary between 0 to a maximum of 60. Higher scores correlate positively with higher levels of anxiety.
Measured: From baseline to 6 months later
Dietary intake
Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
Measured: From baseline to 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start9 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desirée Victoria Montesinos, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758363
- Sponsor's protocol ID
- CE012309
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
- ClinicalTrials.gov ID
- NCT05758363
- Acronym / sponsor ID
- CE012309
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 7 Mar 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.
The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.
Detailed description
The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Consumption of dietary supplement.Consumption of dietary supplement capsules for 6 months. |
| Control Group | Placebo comparator | Other: Consumption of control productIdentically appearing placebo capsules consumed for 6 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age: 30 - 70 YO)
- BMI over 25 kg/m2.
- Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.
Key exclusion criteria (8 listed)
- Subjects with eating disorders.
- BMI less than 25 Kg/m2.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study.
- Unwillingness or inability to comply with clinical trial procedures.
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 |
|---|---|---|
| Consumption of dietary supplement.Consumption of a dietary supplement rich in glutathione, selenium, zinc, vitamin D and EPA/DHA. 1 capsule per day of the dietary supplement with breakfast. | Dietary supplement | Experimental Group |
| Consumption of control productConsumption of 1 capsule per day of control product of identical appearance with breakfast. | Other | Control Group |
Primary outcome
Evaluation of weight loss
Time frame: From baseline to 6 months later
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.
6 secondary outcomes
Quality of life by WHOQOL-BREF
Time frame: From baseline to 6 months later
Quality of life by SF-36
Time frame: From baseline to 6 months later
Depression
Time frame: From baseline to 6 months later
Stress
Time frame: From baseline to 6 months later
Anxiety
Time frame: From baseline to 6 months later
Dietary intake
Time frame: From baseline to 6 months later
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 20 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of dietary supplement. in people with Overweight, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 3 inclusion and 8 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 20 Mar 2024. 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 Spain. 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?
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?
Evaluation of weight loss (time frame: From baseline to 6 months later). 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 20 Mar 2024.