Effectiveness of ResArgin on Adult's Body Composition and Health

NCT ID: NCT06601049

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-02-15

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ResArgin

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

Group Type ACTIVE_COMPARATOR

ResArgin

Intervention Type DIETARY_SUPPLEMENT

Resveratrol-based supplement

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.

Group Type PLACEBO_COMPARATOR

ResArgin

Intervention Type DIETARY_SUPPLEMENT

Resveratrol-based supplement

Interventions

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ResArgin

Resveratrol-based supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Heather Hausenblaus

OTHER

Sponsor Role lead

Responsible Party

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Dr. Heather Hausenblaus

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jacksonville University

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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WDL022024

Identifier Type: -

Identifier Source: org_study_id

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