Evaluation of Metabolic Effects and in Modulation of Food Behaviour of Arom Digest Slim Product in Association With Minimal Nutritional Changes in Overweight Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline Lipids at 60 days (Biochemical assessment)
研究概览
简要总结
The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight reduction along with a series of minimal nutritional interventions.
详细描述
Arom Digest Slim is a blend of fish collagen and essential oils. It will be administered in a group of overweight females wich also undertake minimal nutritional changes. The group will be compared with a group following only minimal nutritional changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •females 18 to 60 years old
排除标准
- •cardiovascular, psychiatric and neurologic chronic conditions and medication
- •acute conditions
- •patients with hypersensitivity to any components of the product
研究组 & 干预措施
Arom Digest Slim and nutritional changes
Subjects take collagen and follow minimal nutritional changes.
干预措施: Arom Digest Slim (Dietary Supplement)
Arom Digest Slim and nutritional changes
Subjects take collagen and follow minimal nutritional changes.
干预措施: Nutritional changes (Behavioral)
Nutritional changes
Subjects only follow minimal nutritional changes
干预措施: Nutritional changes (Behavioral)
结局指标
主要结局
Change from Baseline Lipids at 60 days (Biochemical assessment)
时间窗: baseline and 60 days
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)
Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment)
时间窗: baseline and 60 days
calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405
Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18))
时间窗: baseline and 60 days
Food behavior questionnaire: Three Factor Eating Questionnaire 18 (TEFQ 18) Assessed parameters: Uncontrolled eating - minimal possible value 9, maximal possible value 54 points Cognitive restriction - minimal possible value 3, maximal possible value 12 points Emotional eating - minimal possible value 5, maximal possible value 24 points Higher values represent a worse outcome. Subscales are summed to compute a total score.
Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment)
时间窗: baseline and 60 days
Bioimpedance using InBody720 equipment (Biospace Co., Ltd.) Assessed parameters: A. Body Composition Analysis (9 items): Intracellular Water, Extracellular Water, Protein Mass (kg), Mineral Mass (kg), Body Fat Mass (kg), Total Body Water, Soft Lean Mass (kg), Fat Free Mass (kg), Weight (kg) B. Muscle-Fat Analysis(3 items): Weight (kg), Skeletal Muscle Mass (kg), Body Fat Mass (kg) C. Obesity Diagnosis: Body Mass Index(BMI, kg/m2), Percent Body Fat (%), Waist-Hip Ratio D. Lean Balance (5 items): Right Arm (kg), Left Arm (kg), Trunk (kg), Right Leg (kg), Left Leg (kg) E. Visceral Fat Area: Norma l\<100cm2 Over : 100\~150cm2 Extremely over : \>150cm2 F. Weight Control(4 items): Target Weight (kg), Weight Control(kg), Fat Control(kg), Muscle Control(kg) F. Fitness Score: The Fitness Score is an arbitrary score based on the measured muscle and fat mass for the motivation of the subjects. Under 70 : Weak Type 70\~90 : NormalType Over 90 : Athletic Type
次要结局
未报告次要终点
研究者
Monica Goia-Socol
Assist. Prof. Dr. Monica Goia-Socol, MD, PhD
SC Aromaarmony SRL