Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302276
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2006-03-13
Brief Title:
Weight Loss Maintenance of a New Bioactive Compound Metobes-Long
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Weight Loss Maintenance of a New Bioactive Compound Metobes-Long
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract capsaisin caffeine tyrosine and calcium or placebo taken tid on thermogenesis body fat loss and fecal fat excretion Furthermore if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss
Detailed Description:
It has previously been shown that a combination of tyrosine capsaicin catechines and caffeine may stimulate the sympathetic nervous system and promote satiety lipolysis and thermogenesis In addition dietary calcium may increase fecal fat excretion
Method
80 healthy Danish overweight to obese BMI between 28 and 35 kgm2 18 to 70 years of age subjects of both gender All subjects was be weight stable within 3-kg 2 months prior to study inclusion non-smoking non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds All subjects gave their written consent after verbal and written information about the study The study protocol was approved by The Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the Helsinki II Declaration
The total study period was 12 weeks The intervention design was an 8-weeks randomized 3-arm parallel placebo-controlled and double-blind intervention Prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 34 MJd low caloric diet LCD Only subject who lost more than 4 of their initial body weight after 4 weeks LCD treatment was randomized and continued in the study
The subjects were randomized into 3 balanced groups ie placebo simple or enterocoated release All subjects received dietary instruction to a slightly hypo caloric diet of -300 kcalday after the isoenergetic educational system The dietary advice was reinforced by dietetic consultations every fortnight
Body weight and composition were assessed by DEXA before and after the LCD period four weeks into the randomized period and at completion ie the last day of the study
All participants underwent assessment of energy expenditure by indirect calorimetry in a ventilated hood The first respiratory measurement was on the first day of the intervention and will last for 5 hours
All subjects collected all feces excreted three days prior to respiratory measurement and one day of urine excreted
Method
80 healthy Danish overweight to obese BMI between 28 and 35 kgm2 18 to 70 years of age subjects of both gender All subjects was be weight stable within 3-kg 2 months prior to study inclusion non-smoking non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds All subjects gave their written consent after verbal and written information about the study The study protocol was approved by The Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the Helsinki II Declaration
The total study period was 12 weeks The intervention design was an 8-weeks randomized 3-arm parallel placebo-controlled and double-blind intervention Prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 34 MJd low caloric diet LCD Only subject who lost more than 4 of their initial body weight after 4 weeks LCD treatment was randomized and continued in the study
The subjects were randomized into 3 balanced groups ie placebo simple or enterocoated release All subjects received dietary instruction to a slightly hypo caloric diet of -300 kcalday after the isoenergetic educational system The dietary advice was reinforced by dietetic consultations every fortnight
Body weight and composition were assessed by DEXA before and after the LCD period four weeks into the randomized period and at completion ie the last day of the study
All participants underwent assessment of energy expenditure by indirect calorimetry in a ventilated hood The first respiratory measurement was on the first day of the intervention and will last for 5 hours
All subjects collected all feces excreted three days prior to respiratory measurement and one day of urine excreted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None