Effectiveness of ResArgin on Adult's Body Composition and Health

Dr. Heather Hausenblaus

Status: Active, not recruiting

Conditions: Weight Loss

Treatments: Dietary Supplement: ResArgin

Study type: Interventional

Funder types: Other

Identifiers

NCT06601049

WDL022024

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

ResArgin

Active Comparator group

Description:

A resveratrol-based supplement. Participants will receive a daily oral dose of ResArgin containing \[50 mg/d\] of trans-Resveratrol for 90 days.

Treatment:

Dietary Supplement: ResArgin

placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: ResArgin