Effectiveness of Lifestyle Modification in Combination With Psyllium Husk Fiber Intervention on the Metabolic Health of Centrally Obese School Teachers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sleep quality analysis
研究概览
简要总结
A group of 120 school teachers (male=60, female=60) was divided into four subgroups for sixteen weeks of an interventional study. One group was kept in control while the other three groups were assigned intervention. One group was assigned intervention of lifestyle modification (LSM), the other group assigned the intervention of 5 gm psyllium husk fiber (PSH) two times a day, and the third group assigned the combined intervention of LSM & PSH. Each group comprised of 30 subjects with equal gender bifurcation (15 male and 15 female).
详细描述
The school teachers who qualified for the initial screening and eligibility criteria were formally enrolled in the intervention. An informed consent form was signed by each subject explaining the data privacy and the subject's obligation. School teachers with lifestyle modification were advised to adhere to three major components, i.e., diet modification, physical activity, and behavioral therapy. subjects in the psyllium husk fiber group were assigned the consumption of 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner. subjects in the combined group of psyllium husk fiber and physical activity were assigned both the intervention of psyllium husk fiber @ 5gm two times a day, 30 minutes before breakfast and dinner in swelled gel form with the combination of lifestyle modification, while one group remained as control (without any intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •School teachers aged 40-60 years (male and female)
- •central obesity (where central obesity for Asians is defined as the waist circumference for men ≥ 90 cm and for women ≥ 80 cm
- •with no history of any chronic disease like hypertension, Diabetes, Cardiovascular diseases, taking of any regular medication, food allergies, smoking
- •physical disabilities impairing the food intake and mobility, qualified the inclusion criteria.
排除标准
- •Pregnant or lactating female school teachers were also excluded during screening.
- •Subjects with an allergy to psyllium husk fiber, history of drug abuse, or any psychological or emotional disorder that might prevent the completion of the study were also excluded.
研究组 & 干预措施
Control group
Group-I comprised of 30 subjects, 15 male and 15 female. The group was assigned no intervention and kept as the control group.
干预措施: Control (Other)
LSM group
Group II comprised 30 subjects with the equal bifurcation of male and female. Group II was assigned the intervention of lifestyle modification (the combination of diet, physical activity, and behavior therapy)
干预措施: Effect of life style modification (Diet, Behavior and physical activity) (Behavioral)
PSH group
Group III comprised of 30 subjects, 15 male and 15 female. Group III was assigned the 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner.
All the subjects in the physical demonstration were briefed about the preparation and usage of psyllium husk fiber.
干预措施: effect of 10 gm psyllium husk fiber twice a day, 30 minutes before breakfast and dinner (Dietary Supplement)
LSM&PSH
Group IV comprised of 30 subjects, 15 male and 15 female. Group IV was assigned both the intervention of psyllium husk fiber @ 5gm two times a day, 30 minutes before breakfast and dinner in swelled gel form with the combination of lifestyle modification
干预措施: Combined effect of 10 gm Psyllium husk fiber and lifestyle modification (Combination Product)
结局指标
主要结局
Sleep quality analysis
时间窗: 16 weeks
wil use Pittesburge Sleep Quality Index score (ranging from 0 to 6. where 0 reflect best sleep quality and 7 represent the worst sleep quality)
Anthropometry
时间窗: 16 weeks
weight (Kg),
Lipid Profile
时间窗: 16 weeks
Triglyceride, LDL, HDL and cholesterol. unit used was mg/dl.
abdomen and epigastric health
时间窗: 16 weeks
Likert scale (0-7). 0 represents good health and 7 represent worst epigastric and abdominal health
Waist circumference
时间窗: 16 weeks
Measure waist circumference in cm (centimeter)
height (cm)
时间窗: 16 weeks
Measure height in cm (centimeter)
BMI
时间窗: 16 weeks
weight and height will be combine to calculate the BMI (kg/m\^2)
次要结局
- Insulin resistance(16 weeks)
- high sensitive C reactive protein(16 weeks)
研究者
Amjad Ali Bacha
Dr.
University of Peshawar