CTRI/2018/02/012016已完成未知
EFFECTS OF CIRCADIAN RESTRICTED FEEDING ON BODY WEIGHT, BLOOD PRESSURE AND FASTING BLOOD GLUCOSE
International College of Nutrition0 个研究点目标入组 47 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Background. Halberg et al demonstrated for the first time that circadian restricted feeding in the morning is associated with decrease in weight whereas feeding same energy in the night may be associated with weight gain. There is lack of further evidence in humans on this area. This study aims to reexamine, whether circadian restricted feeding has similar response in Indian subjects.
排除标准
- •Multicenter study.
- •1.Dr RB Singh,MD, FICN, HHRI, Moradabad
- •2. Dr Mukta Singh,PhD, Deptt of Home Science, BHU, Varanasi (UP)
- •Subjects and methods.
- •Ethical Clearance and written informed consent. After written informed consent from all the subjects, ethical clearance was obtained by the the Halberg Hospital and Research Institute ethic committee, Moradabad (UP) registered with DCI.
- •Recruitment of subjects. Subjects were recruited for this study by publicizing via distribution of pamphlets in local news, papers and announcements via notice board of the hospitals. Exclusion criteria were; taking any drug therapy for a metabolic diseases; obesity, diabetes, thyroid disease refusal in giving consent, any other chronic disease e g chronic dysentery, cancer and those above 60 years etc.
- •Study Design. The study was conducted in a crossover design in which all the subjects were randomly selected by computer generated numbers. The study included; a 1 week observation period, a 4 week intervention period of feeding in the morning (8.00 to 9.30AM), a 4 week washout period and finally a 4 week intervention period by feeding in the evening (8.00 to 9.30PM).
- •Inclusion criteria. Subjects were included, if they volunteered to take majority of the totals one day meals (approximately 2000 Kcal./day) in the evening or morning at least for 4 weeks.
- •Clinical data such as age, sex, body weight, height, waist and hip circumference were measured by a validated questionnaire, as described in our earlier studies. Physical activity was assessed by validated questionnaire and included both occupational and spare time activity and subjects were classified in to sedentary, mild, moderate and heavy activity. Dietary intakes were obtained by validated questionnaire completed by trained dietitian by asking probing questions and by using food measures, food models and dietary diaries filled by the subjects during the total period of study. Blood pressures were recorded by same professional in sitting position and average of last two readings was considered final blood pressure. Blood glucose was obtained after overnight fasting by a calibrated glucometer in all the subjects.
- •Statistical analysis would be conducted at Halberg Chronobiology Center, University of Minnesota Medical School, Minneapolis, USA. The significance for ordinal variable would be obtained by paired t test and for continuous variable by analysis of variance while comparing data of subjects with feeding in the evening verses feeding in the evening. Only p values <0.05 and two tailed t test would be considered significant.
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