Changes in Olfactory and Taste Behavior in Overweight / Obese Subjects Undergoing Fasting Mimicking Diet (FMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Sniffing stick test change
研究概览
简要总结
Literature experiences demonstrated the impact of medically-assisted pulsed fasting on olfactory behavior in both the animal and human models and - conversely - the lack of homogeneous results linked - up to now - to administrations of pulsed fasting which are not widely codified.
Thus, objective of this study protocol is to evaluate the olfactory-gustatory aspects and blood patterns of a group of subjects suffering from obesity / overweight after a 6-month period of Fasting Mimicking Diet (FMD) (Group A) - consisting of a caloric restriction regimen - compared to a group of homogeneous subjects observing their own eating habits (Group B) which - according to a "cross-over" model - will undergo FMD in the following semester during which the subjects belonging to Group A will observe their eating habits.
详细描述
A group of obese and/or overweighted patients who did not pass screening criteria (BMI andor neuropsychological testing) to undergo surgical procedure aimed at reducing weight (grastrectomy, bypass, other…) will follow a 6-month period of FMD followed by 6-month period of routinary eating behaviour (Group A) or viceversa (Group B).
All the patients will undergo - before and after the administration of FMD or the routinary diet habit - a battery of:
- Olfactory test (sniffin' stick test)
- Taste Test (Taste strips)
- Blood Samples including: IGF-1, IGFBP1/3, VEGF, insulin, adiponectin, c reactive protein, plasma ghrelin, serum glucose, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), total cholesterol, triglycerides (TGs), high density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol, erythrocyte sedimentation rate (ESR), conjugated and unconjugated bilirubin, uraemia, serum creatinine and leptin.
- anthropometeric measures, including height and body weight, BMI, waist circumference (WC), estimation of fat mass (FM, in % and Kg), skeletal muscle mass (MM, in % and Kg) and grade of visceral fat (VF level)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or
- •non-responders to any previous dietary / nutritional treatment
- •BMI > 25
排除标准
- •Subjects under the age of 18 and over 75 years.
- •Subjects already undergoing bariatric surgical treatment
- •Women who are pregnant or breastfeeding
- •Hormonal therapies and / or chemotherapy in place
- •Active mental or psychiatric illness
- •Addiction to drugs of abuse or alcohol
- •other acute or chronic systemic disorders
- •Severe hypertension (systolic blood pressure> 200 mm Hg and / or diastolic blood pressure> 105 mm Hg)
- •Visual impairment (for completion of neuropsychological tests)
- •Inability to complete home FMD
研究组 & 干预措施
Group A
Diet followed by routine eating
干预措施: Fasting Mimicking Diet (FMD) (Dietary Supplement)
Group B
Routine eating followed by diet
干预措施: Routinary diet habits (Dietary Supplement)
Group A
Diet followed by routine eating
干预措施: Routinary diet habits (Dietary Supplement)
Group B
Routine eating followed by diet
干预措施: Fasting Mimicking Diet (FMD) (Dietary Supplement)
结局指标
主要结局
Sniffing stick test change
时间窗: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Quantitative screening of olfactory performance
Taste Strips
时间窗: From date of randomization until the date of first documented progression, assessed at the 6th and 12 months
Quantitative assessment of taste performance
次要结局
- Incidence of abnormal laboratory tests results(From date of randomization until the date of first documented progression, assessed at the 6th and 12 months)
- anthropometric measures(From date of randomization until the date of first documented progression, assessed at the 6th and 12 months)