A COMPARATIVE STUDY TO ASSESS THE ASSOCIATION BETWEEN DIFFERENT PATTERNS IN THE TIMING OF THE SLEEP & / OR DIET WITH BIOMARKERS OF THYROID FUNCTION AND QUALITY OF LIFE IN HEALTHY INDIVIDUALS.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 试验地点
- 1
研究概览
简要总结
Title - A COMPARATIVE STUDY TO ASSESS THE ASSOCIATION BETWEEN DIFFERENT PATTERNS IN THE TIMING OF THE SLEEP & /OR DIET WITH BIOMARKERS OF THYROID FUNCTION AND QUALITY OF LIFE IN HEALTHY INDIVIDUALS.
Background - Our 24-hour ayurvedic biological cycles influences the sleeping and waking cycle, the release of hormones, eating pattern , digestion, temperature of our body and other important bodily functions. The ayurvedic or circadian cycle affects the gene expression metabolism and function of different system. Understanding the circadian rhythm , causes for its derangement , its pathogenesis and ways to reset the circadian rhythm.
OBJECTIVE -
-
To assess the core physiological outcome of different pattern in the timing of the sleep & / or diet on thyroid profile biomarkers in healthy individuals.
-
To identify specific pattern and their individual effect on thyroid profile biomarkers in healthy individuals.
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To assess the association between different pattern in the timing of the sleep & / or diet and quality of life in healthy individuals.
Study Design - comparative observational study
Participants - healthy Individuals aged 20 - 40 years
Method -
Subjective Criteria -
-
SWASTHYA ASSESSMENT SCALE (CCRAS/IGIB)
-
PSQI
-
MORNINGNESS - EVENINGNESS QUESTIONNAIRE
-
CHRONONUTRITION PROFILE
-
WHO QUALITY OF LIFE SCALE
Objective Criteria
- TSH
2.T3
3.T4
-
Free Thyroxine (fT4)
-
Free Triodothyronine (fT4)
-
FGF-21
-
Ultrasensitive TSH
Outcomes -
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There will be a measurable association between different sleep and / or diet timing patterns and thyroid profile biomarkers.
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Identification of specific sleep and /or diet timing pattern with variations in thyroid biomarkers.
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Association between sleep and/ or diet timing pattern and quality of life scores as measured by a validated questionnaire.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria of group A
- •Apparently healthy study participants in the age group 20 – 40 years of either sex will be included in the study, irrespective of their caste, creed or religion
- •Subject willing to participate and able to give written informed consent.
- •Subjects having aligned (normal pattern) sleep timing & duration with morning alertness and aligned (normal pattern) diet timing & frequency for minimum 5 days in a week.
- •Inclusion criteria of group B,C and D
- •Subjects having either misaligned (deviation from normal pattern) sleep or diet or both to their respective group.
- •Subject having intermediate or evening alertness by MEQ.
排除标准
- •Exclusion criteria of group A, B, C and D
- •Patients with a major psychiatric illness like schizophrenia , depressive psychosis etc.
- •Patients with any systemic or metabolic disorder
- •Pregnant females, lactating mothers, perimenopausal and menopausal women.
- •Patients with alcohol dependency or drug dependency, that on hypnotic medicine or other drugs which known to cause drowsiness.
研究者
Vasundhara
All India Institute of Ayurveda New Delhi