Effectiveness of ResArgin on Adult's Body Composition and Health

N/AActive Not RecruitingNCT06601049

Dr. Heather Hausenblaus60 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Weight Loss

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of intervention at 90 days

Secondary Outcomes

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.

Time frame: Change from Baseline to Day 90