Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256516
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2005-11-16
Brief Title:
Low Carbohydrate Portfolio or Eco-Atkins Diet
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Low Carbohydrate Portfolio or Eco-Atkins Diet
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Exchange of the butter eggs cheese and meat in the Atkins diet for soy protein foods other vegetable proteins including gluten and vegetable fats nuts avocado olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss
Detailed Description:
Subjects Thirty overweight hyperlipidemic subjects who wish to lose weight
Design
Protocol Metabolic Study will be randomized to either the Eco-Atkins diet 15 subjects or NCEP diet 15 subjects The diets will be provided for the one month period with the aim of inducing the same weight loss 5 kg as seen in the first month of the published reports on the Atkins diet The diets will provide about 60 of estimated energy requirements Subjects will be provided with their diets at weekly intervals by courier and intakes adapted to ensure that they achieve their target weight loss goal Fasting weight will be taken at weekly intervals together with blood pressure and blood for lipids glucose and insulin assessment
Protocol Ad Libitum Study After completing the metabolic phase of the study the thirty subjects will be asked to continue with the diet to which they were randomized for a further 6-month period During this ad libitum trial study foods will not be provided This longer less tightly controlled study will establish the value of this diet in real life situations This will be required to support our shorter term well-controlled more detailed metabolic study Fasting weight will be taken at monthly intervals together with blood pressure and blood for lipids glucose and insulin assessment
Study Details Participants will come after a 12h overnight fast to the Risk Factor Modification Centre at St Michaels Hospital or the Department of Nutritional Sciences University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the metabolic study and monthly during the ad libitum study Prior to the start of the study participants will be instructed on details of the study diet protocol They will also be asked to maintain a constant level of physical activity throughout the course of the study At all visits body weight in kg will be obtained in indoor clothing without shoes and blood pressure will be taken twice in the dominant arm after participants have been seated for at least 20 minutes Height in cm will be recorded at the first visit Body composition measurements will be measured using bioelectric impedance at baseline and week 4 of the metabolic phase and months 3 and 6 of the ad libitum phase Throughout the study period participants will maintain the diet prescribed on their initial visit At each visit participants will provide a fasting blood sample and seven-day food records will be collected During the last week of the metabolic and ad libitum study 24h fecal and urine collections will be completed
Design
Protocol Metabolic Study will be randomized to either the Eco-Atkins diet 15 subjects or NCEP diet 15 subjects The diets will be provided for the one month period with the aim of inducing the same weight loss 5 kg as seen in the first month of the published reports on the Atkins diet The diets will provide about 60 of estimated energy requirements Subjects will be provided with their diets at weekly intervals by courier and intakes adapted to ensure that they achieve their target weight loss goal Fasting weight will be taken at weekly intervals together with blood pressure and blood for lipids glucose and insulin assessment
Protocol Ad Libitum Study After completing the metabolic phase of the study the thirty subjects will be asked to continue with the diet to which they were randomized for a further 6-month period During this ad libitum trial study foods will not be provided This longer less tightly controlled study will establish the value of this diet in real life situations This will be required to support our shorter term well-controlled more detailed metabolic study Fasting weight will be taken at monthly intervals together with blood pressure and blood for lipids glucose and insulin assessment
Study Details Participants will come after a 12h overnight fast to the Risk Factor Modification Centre at St Michaels Hospital or the Department of Nutritional Sciences University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the metabolic study and monthly during the ad libitum study Prior to the start of the study participants will be instructed on details of the study diet protocol They will also be asked to maintain a constant level of physical activity throughout the course of the study At all visits body weight in kg will be obtained in indoor clothing without shoes and blood pressure will be taken twice in the dominant arm after participants have been seated for at least 20 minutes Height in cm will be recorded at the first visit Body composition measurements will be measured using bioelectric impedance at baseline and week 4 of the metabolic phase and months 3 and 6 of the ad libitum phase Throughout the study period participants will maintain the diet prescribed on their initial visit At each visit participants will provide a fasting blood sample and seven-day food records will be collected During the last week of the metabolic and ad libitum study 24h fecal and urine collections will be completed
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