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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.
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
o N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ResArgin | Dietary Supplement | Resveratrol-based supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of intervention at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville University | Jacksonville | Florida | 32111 | United States |
Gateway Health Alliance will determine the IPD sharing plan
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change from Baseline to Day 90 |