Clinical trial NCT06601049: Effectiveness of ResArgin on Adult's Body Composition and Health
Official title: Effectiveness of ResArgin on Adult's Body Composition and Health: a Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss
Lead sponsor: Jacksonville University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

o N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).

Eligibility criteria: Inclusion Criteria:

* overweight and mildly obese adults
* age range between 25 to 60 years

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days
timeFrame: From enrollment to the end of intervention at 90 days
Secondary outcomes:
measure: Change from baseline in health-related quality of life, sleep quality, activity, and mood at 90 days
timeFrame: Change from Baseline to Day 90
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville University
state: Florida
Study officials:
References: