Effectiveness of ResArgin on Adult's Body Composition and Health

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: ResArgin

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32111
      • Jacksonville University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ResArgin; A resveratrol-based supplement. Participants will receive a daily oral dose of ResArgin containing [50 mg/d] of trans-Resveratrol for 90 days.	Dietary supplement: ResArgin; Resveratrol-based supplement
Placebo Comparator: placebo; 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.	Dietary supplement: ResArgin; Resveratrol-based supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Change from Baseline to Day 90

Collaborators and Investigators

• Sponsor: Dr. Heather Hausenblaus

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: WDL022024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Gateway Health Alliance will determine the IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No