Effectiveness of ResArgin on Adult's Body Composition and Health

NCT06601049 | Active Not Recruiting

• 1 other identifier: WDL022024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in health-related quality of life, sleep quality, activity, and mood at 90 days

  Change from Baseline to Day 90

Study Arms (2)

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.

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.

Dietary Supplement: ResArgin

Interventions

ResArgin DIETARY_SUPPLEMENT

Resveratrol-based supplement

ResArgin; placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Heather Hausenblaus: lead

Study Sites (1)

Jacksonville University

Jacksonville, Florida, 32111, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: February 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)