Effect of Consumption of Caraway on Treatment of Obesity
Atslēgvārdi
Abstrakts
Apraksts
A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.
the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).
Datumi
| Pēdējoreiz pārbaudīts: | 03/31/2013 |
| Pirmais iesniegtais: | 03/25/2013 |
| Paredzētā reģistrācija iesniegta: | 04/14/2013 |
| Pirmais izlikts: | 04/15/2013 |
| Pēdējais atjauninājums iesniegts: | 04/14/2013 |
| Pēdējā atjaunināšana ievietota: | 04/15/2013 |
| Faktiskais studiju sākuma datums: | 08/31/2012 |
| Paredzamais primārās pabeigšanas datums: | 11/30/2012 |
| Paredzamais pētījuma pabeigšanas datums: | 11/30/2012 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Dietary Supplement: caraway sample
Dietary Supplement: Placebo
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: caraway sample caraway sample | Dietary Supplement: caraway sample |
| Active Comparator: Placebo | Dietary Supplement: Placebo |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 20 Years Uz 20 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - overweight and obese women (BMI> 25) - aged 20-55 years old - healthy subjects Exclusion Criteria: - Pregnant and lactating women - Thyroid disease - type I or II diabetes mellitus - hypertension (systolic BP 140 and/or diastolic BP 90) - endocrine dysfunction - impaired liver function - chronic renal disease - cardiovascular disease - primary dyslipidemia - myopathy - patients using drugs which affect on metabolism or appetite - a maintained weight loss in the preceding 3 months - meals not eaten at regular intervals - participation in another investigation study within the past 30 days - a history of alcohol or drug abuse within the past year - smoking - a history of sleep disorders - clinical depression or other psychiatric conditions - abnormal obese - allergy or sensitivity to any of the 'active' or 'placebo' product ingredients |
Rezultāts
Primārie rezultāti
1. Change in body mass index [Baseline and 12 weeks]
Sekundārie iznākuma mērījumi
1. change in all blood parameters [Baseline and 12 weeks]
2. Change in vital parameters (systolic and diastolic blood pressure and pulse rate) [Baseline and 12 weeks]
3. Change in body weight [Baseline and 12 weeks]
4. Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm) [Baseline and 12 weeks]
5. Change in appetite [Baseline and 12 weeks]
6. Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage [Baseline and 12 weeks]
7. Change in body weight (kg) [Baseline and 12 weeks]
8. Change in basic and active metabolic rate [Baseline and 12 weeks]
9. Change in food intake [Baseline and 12 weeks]
10. Change in urine specific gravity [Baseline and 12 weeks]
