Weight LossNCT06601049
Effectiveness of ResArgin on Adult's Body Composition and Health
A study testing ResArgin in people with Weight Loss, run by Dr. Heather Hausenblaus at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- ResArgin
- 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 siteUnited States
- Study dates
- 15 Aug 2024to 15 Feb 2025
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight and mildly obese adults
- age range between 25 to 60 years
Who cannot join
- metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction.
- history of seizures or epilepsy-related disorders
- musculoskeletal issues that would prohibit them from engaging in spontaneous activity,
- metabolic disorder
- sleep disorder
- psychiatric condition
Show all 15Show fewer
- dietary aversions or restrictions including any animal sources of protein, dairy, fruits/vegetables, nut/seed allergy, eggs, and wheat/gluten or are currently following a carbohydrate restricted (under 20%) habitual diet.
- smokers
- consume excessive amounts of alcohol (>3 drinks/d)
- actively intermittent fasting
- actively trying to lose weight or have lost more than ± 3kg in previous 3 months
- pregnant
- nursing
- trying to conceive
- changed their birth control in the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville University
Jacksonville, Florida, 32111
About this study
Official title: Effectiveness of ResArgin on Adult's Body Composition and Health: a Randomized Double-Blind Placebo-Controlled Trial
The goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. The main questions it aims to answer are:
Does ResArgin improve muscle loss? Does ResArgin improve sleep quality, activity, mood, and body satisfaction.
Read more
Researchers will compare ResArgin to a placebo (a look-alike substance that contains no active ingredients) to see if ResArgin works to improve muscle loss and related health outcomes.
Participants will:
Take ResArgin or the Placebo every day for 3 months
Assessment will occur at Baseline, Day 30, Day 60, and Day 90.
Participants will complete a daily diary of their mood and health.
Read the detailed description
Study Purpose: Examine the effectiveness of ResArgin in attenuating muscle loss during a period of fat loss in overweight and mildly obese men and women.
Outcomes: Primary outcomes will be body composition. Secondary outcomes will be physical activity, food cravings, health-related quality of life, body satisfaction, basal metabolic rate, sleep behaviors, mood, anxiety, and perceived stress.
Study Design • Randomized double-blind placebo-controlled trial
- N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).
- Conditions
- Weight Loss
- Being tested
- ResArgin
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResArginDietary supplement
Resveratrol-based supplement
| Study group | Role | What they receive |
|---|---|---|
| ResArgin | Active comparator | A resveratrol-based supplement. Participants will receive a daily oral dose of ResArgin containing [50 mg/d] of trans-Resveratrol for 90 days. Receives: Dietary Supplement: ResArgin |
| placebo | Placebo comparator | Placebo consists of oat hull. Participants receive a daily oral dose of a placebo matching the appearance and dosage form of ResArgin for 90 days. Receives: Dietary Supplement: ResArgin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days
This will be assessed objectively by a trained health professional.
Measured: From enrollment to the end of intervention at 90 days
Secondary outcomes (1)
Change from baseline in health-related quality of life, sleep quality, activity, and mood at 90 days
Health-related quality of life where zero is equivalent to high quality of life and 30 indicates the worst quality of life. Sleep quality as assessed by the Insomnia Severity Index where 0 indicates excellent sleep quality and 28 indicates worst sleep quality. Mood as assessed by the Profile of Mood States where 0 = Not at all and 4 = Extremely. Sleep quality and activity as assessed by the Oura Ring where 0 indicates poor sleep quality or activity and 100 indicates excellent sleep quality and activity. Bioelectrical impedance scale assessed percent body fat where a higher score indicates a higher percent body fat.
Measured: Change from Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Aug 2024
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Heather Hausenblaus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Heather Hausenblaus, Jacksonville University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601049
- Sponsor's protocol ID
- WDL022024
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Gateway Health Alliance will determine the IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of ResArgin on Adult's Body Composition and Health: a Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06601049
- Acronym / sponsor ID
- WDL022024
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Heather HausenblausUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. The main questions it aims to answer are:
Does ResArgin improve muscle loss? Does ResArgin improve sleep quality, activity, mood, and body satisfaction.
Researchers will compare ResArgin to a placebo (a look-alike substance that contains no active ingredients) to see if ResArgin works to improve muscle loss and related health outcomes.
Participants will:
Take ResArgin or the Placebo every day for 3 months
Assessment will occur at Baseline, Day 30, Day 60, and Day 90.
Participants will complete a daily diary of their mood and health.
Detailed description
Study Purpose: Examine the effectiveness of ResArgin in attenuating muscle loss during a period of fat loss in overweight and mildly obese men and women.
Outcomes: Primary outcomes will be body composition. Secondary outcomes will be physical activity, food cravings, health-related quality of life, body satisfaction, basal metabolic rate, sleep behaviors, mood, anxiety, and perceived stress.
Study Design • Randomized double-blind placebo-controlled trial
- N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ResArgin | Active comparator | Dietary Supplement: ResArginA resveratrol-based supplement. Participants will receive a daily oral dose of ResArgin containing [50 mg/d] of trans-Resveratrol for 90 days. |
| placebo | Placebo comparator | Dietary Supplement: ResArginPlacebo consists of oat hull. Participants receive a daily oral dose of a placebo matching the appearance and dosage form of ResArgin for 90 days. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- overweight and mildly obese adults
- age range between 25 to 60 years
Key exclusion criteria (15 listed)
- metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction.
- history of seizures or epilepsy-related disorders
- musculoskeletal issues that would prohibit them from engaging in spontaneous activity,
- metabolic disorder
- sleep disorder
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 |
|---|---|---|
| ResArginResveratrol-based supplement | Dietary supplement | ResArgin, placebo |
Primary outcome
Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days
Time frame: From enrollment to the end of intervention at 90 days
This will be assessed objectively by a trained health professional.
1 secondary outcome
Change from baseline in health-related quality of life, sleep quality, activity, and mood at 90 days
Time frame: Change from Baseline to Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Gateway Health Alliance will determine the IPD sharing plan
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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 ResArgin in people with Weight Loss, run by Dr. Heather Hausenblaus at 1 site in United States.
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 15 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 19 Sep 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 United States. 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?
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?
Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days (time frame: From enrollment to the end of intervention at 90 days). 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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.