None listed
Conditions
Interventions
Control Intervention1: Effect of eating in the morning: Eating majority(80%) of the energy in the morning in a
Randomized, crossover trial
Sponsors
International College of Nutrition
Halberg Chronobiology Center
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is possible that feeding in the evening would be associated with gain in weight whereas feeding same amount of energy in the morning would be associated with reduction in weight or no change in weight.Timepoint: Observation period 1 week Feeding in morning 4 week Washout period 4 week Feeding in evening 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase in weight or no change in weight or decrease in weightTimepoint: after 4 weeks feeding in evening;Reduction or increase in fasting blood glucose and blood pressuresTimepoint: after 4 weeks follow up on intervention of circadian restriction and 4 weeks washout period | — |
Countries
India
Contacts
Public ContactRam B Singh
Halberg Hospital and Research Institute
Outcome results
None listed