30 Day Insulin Balance Metabolic Health Optimization Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Waist Circumference Measured by Flexible Tape Measure
研究概览
简要总结
Explore how a dietary supplement can help support healthy insulin levels and its impact on weight, fatigue, and sugar cravings. The Insulin Balance Formula and Hormetics Weight Optimization System is designed for people who are generally healthy and want to support and maintain healthy insulin levels to reach general health goals.
详细描述
Treatment activities:
Daily Activity: Take 3 capsules of the Insulin Balance Supplement daily, ideally 1 capsule before each meal or all at once for convenience. Begin with 1 capsule to assess tolerance and increase to the recommended dose. Take on an empty stomach or with a meal if needed.
Assessments and frequency:
Body Composition Measurement: Complete the assessment as required. PROMIS Sleep Disturbance Scale: Complete the assessment as required. Carbohydrate Craving Questionnaire: Complete the assessment as required. After Meal Hunger & Fatigue Perception: Complete the assessment as required.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18+ who are generally healthy
- •Ability to read and comprehend English
- •Ability to willfully consent and follow study procedures and tasks
排除标准
- •Individuals with Known Allergies
- •Pregnant or Nursing Individuals
- •Individuals with Insulin Disorders
- •Individuals with GI Disorders
- •Individuals with Mental Health Conditions
- •Individuals with Sleep Disorders
- •Individuals on Medication
- •Athletes under Specific Regulations
- •Individuals Sensitive to Fatigue
研究组 & 干预措施
Single Arm longitudinal where participants act as their own control
Single Arm longitudinal where participants act as their own control
干预措施: Insulin Balance Formula - Hormetics Weight Optimization System (Dietary Supplement)
结局指标
主要结局
Waist Circumference Measured by Flexible Tape Measure
时间窗: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)
Waist circumference will be measured in centimeters (cm) using a non-elastic, flexible anthropometric tape measure. Measurements will be taken at the midpoint between the lowest rib and the iliac crest with the participant standing, at the end of a normal exhalation. Two measurements will be obtained, and the average value will be recorded.
PROMIS Sleep Disturbance Scale
时间窗: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)
Measurement Scale: The PROMIS Sleep Disturbance Scale is a standardized, participant-reported questionnaire consisting of multiple items rated on a 5-point Likert scale (typically ranging from 1 = "Not at all" to 5 = "Very much"). Item responses are summed and converted to a T-score standardized to the general population (mean = 50, standard deviation = 10). Score Interpretation: Higher scores indicate greater sleep disturbance (worse sleep quality), while lower scores indicate better sleep quality.
Carbohydrate Craving Questionnaire
时间窗: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30)
Measurement Scale: The Carbohydrate Craving Questionnaire (CCQ) is a validated, participant-reported questionnaire designed to assess the frequency and intensity of carbohydrate-related cravings. Items are rated on a Likert-type scale (typically ranging from 1 = "Strongly disagree" to 6 or 7 = "Strongly agree," depending on the CCQ version). Item responses are summed to generate a total score. Score Interpretation: Higher total scores indicate greater carbohydrate craving severity, while lower scores indicate lower levels of carbohydrate craving.
After Meal Hunger & Fatigue Perception
时间窗: Assessed at baseline prior to intervention initiation (Day 0) and at study completion (Day 30), along with random repetitions 6 times per 2 weeks throughout study.
This survey aims to understand how individuals perceive different stages of hunger and fatigue after their most recent meal. The respondents are required to select the option that best describes their current state of hunger or fullness, based on a scale of 1 through 10, with 10 being the most favorable. In addition, this survey measures current state of hunger-associated fatigue from "very drowsy" to "very alert" with "very alert" being the most favorable.
次要结局
未报告次要终点