Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01642849
Status:
UNKNOWN
Last Update Posted:
2012-07-17
First Post:
2012-07-03
Brief Title:
Effect of Diet Composition on Weight Change and Metabolic Parameters
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Effect of Diet Composition on Weight Change and Metabolic Parameters
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
RECRUITING
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:
This study will assess the effect of high protein HP and high carbohydrate HC diets on weight loss and other metabolic parameters
Rationale The prevalence of obesity is on the rise in the US The health hazards of obesity have been well established The detrimental effects of obesity on cardiovascular metabolic and psychological parameters as well as the excess cost to the national health budget are astounding One way of treatment and prevention of obesity has been the use of diet and exercise In the absence of well-established superiority of one diet over another different scientifically unproven diets are in common use A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals Another factor has been the long-term adherence to such weight loss regimens which in general have been poor Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets but definite long-term studies are sparse For this study the investigators will recruit and study 24 normal pre-menopausal obese women 12 on HP diet and 12 on HC diet and compare their weight loss and changes in metabolic parameters between the two diets
Rationale The prevalence of obesity is on the rise in the US The health hazards of obesity have been well established The detrimental effects of obesity on cardiovascular metabolic and psychological parameters as well as the excess cost to the national health budget are astounding One way of treatment and prevention of obesity has been the use of diet and exercise In the absence of well-established superiority of one diet over another different scientifically unproven diets are in common use A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals Another factor has been the long-term adherence to such weight loss regimens which in general have been poor Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets but definite long-term studies are sparse For this study the investigators will recruit and study 24 normal pre-menopausal obese women 12 on HP diet and 12 on HC diet and compare their weight loss and changes in metabolic parameters between the two diets
Detailed Description:
Population Recruit and study 24 pre-menopausal women with the following inclusion criteria
Age range 20 yrs to 50 yrs BMI 30 kgm2 to 55 kgm2 Fasting glucose 110 mgdl and 120 minute OGTT 170 mgdl glucose Design The study is designed to determine the follow
To compare the effects of high protein HP versus high carbohydrate HC diet during energy restriction on weight loss body composition lean and fat body mass and bone mineral density in a free living out patient setting
To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity protein and muscle break down lipoprotein metabolism and basal metabolic rate
Procedures SCREENING VISIT 1Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit VS1 A brief study overview will be given along with a brief history and physical examination height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test OGTT to determine normal glucose handling
SCREENING VISIT 2 VS2Individuals fulfilling all the criteria will be contacted and invited for a second screening visit VS2 Block food frequency questionnaire to assess baseline dietary profile will be given along with a pre-study orientation with the help of a nutritionist
SCREENING VISIT 3 VS3 At the final screening visit VS3 the food diary will be reviewed Individuals will be randomized into one of the two diet groups using a randomization table Participants will be asked to participate in the additional studies of euglycemic hyperinsulinemic clamp and indirect calorimetry
Study participants will either follow a HP or a HC diet for 6 months where all food is supplied to them Randomization will be performed using a randomization table HP diet will be based on 30 Kcals from protein 40 Kcals from carbohydrate CHO and 30 Kcals from fat In contrast HC diet will comprise 15 Kcals from protein 55 Kcals from CHO and 30 Kcals from fat Subjects will come in weekly for their food pick up and weight checks
Age range 20 yrs to 50 yrs BMI 30 kgm2 to 55 kgm2 Fasting glucose 110 mgdl and 120 minute OGTT 170 mgdl glucose Design The study is designed to determine the follow
To compare the effects of high protein HP versus high carbohydrate HC diet during energy restriction on weight loss body composition lean and fat body mass and bone mineral density in a free living out patient setting
To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity protein and muscle break down lipoprotein metabolism and basal metabolic rate
Procedures SCREENING VISIT 1Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit VS1 A brief study overview will be given along with a brief history and physical examination height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test OGTT to determine normal glucose handling
SCREENING VISIT 2 VS2Individuals fulfilling all the criteria will be contacted and invited for a second screening visit VS2 Block food frequency questionnaire to assess baseline dietary profile will be given along with a pre-study orientation with the help of a nutritionist
SCREENING VISIT 3 VS3 At the final screening visit VS3 the food diary will be reviewed Individuals will be randomized into one of the two diet groups using a randomization table Participants will be asked to participate in the additional studies of euglycemic hyperinsulinemic clamp and indirect calorimetry
Study participants will either follow a HP or a HC diet for 6 months where all food is supplied to them Randomization will be performed using a randomization table HP diet will be based on 30 Kcals from protein 40 Kcals from carbohydrate CHO and 30 Kcals from fat In contrast HC diet will comprise 15 Kcals from protein 55 Kcals from CHO and 30 Kcals from fat Subjects will come in weekly for their food pick up and weight checks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1-09-CR-32 | OTHER_GRANT | American Diabetes Association | None |