Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03528317
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2018-04-24
Brief Title:
Alternate Day Fasting Combined With a High Protein Background Diet
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
Status:
COMPLETED
Status Verified Date:
2021-01
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 aims of this study are as follows AIM 1 To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein ADF-HP diet AIM 2 To examine the effects of an ADF-HP diet on metabolic disease risk factors plasma lipids fasting glucose fasting insulin insulin resistance
Detailed Description:
Background Accumulating evidence suggests that alternate day fasting ADF is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk ADF regimens include a feast day where food is consumed ad-libitum over 24 h alternated with a fast day where intake is limited to 600 kcal over 24 h What has yet to be elucidated is whether consuming a high protein diet as meal replacements during ADF is effective for weight loss weight maintenance and metabolic disease risk reduction in individuals with obesity
Objective The aims of this study are as follows AIM 1 To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein ADF-HP diet AIM 2 To examine the effects of an ADF-HP diet on metabolic disease risk factors plasma lipids fasting glucose fasting insulin insulin resistance
Methods A 24-week single-center longitudinal pilot study will be conducted to test the study objectives The trial will be divided into 2 consecutive intervention periods 1 12-week weight loss period and 2 12-week weight maintenance period Subjects with obesity will participate in an ADF-HP alternate day fasting-high protein diet 600 kcal fast day alternated with ad libitum feast day 35 kcal as protein ADF-HP subjects will consume the Optifast HP Shake Mix Nestle on each day of the trial Body weight insulin glucose and insulin resistance will be measured at baseline week 12 and week 24
Significance These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight maintain weight loss and sustain reductions in metabolic disease risk
Objective The aims of this study are as follows AIM 1 To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein ADF-HP diet AIM 2 To examine the effects of an ADF-HP diet on metabolic disease risk factors plasma lipids fasting glucose fasting insulin insulin resistance
Methods A 24-week single-center longitudinal pilot study will be conducted to test the study objectives The trial will be divided into 2 consecutive intervention periods 1 12-week weight loss period and 2 12-week weight maintenance period Subjects with obesity will participate in an ADF-HP alternate day fasting-high protein diet 600 kcal fast day alternated with ad libitum feast day 35 kcal as protein ADF-HP subjects will consume the Optifast HP Shake Mix Nestle on each day of the trial Body weight insulin glucose and insulin resistance will be measured at baseline week 12 and week 24
Significance These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight maintain weight loss and sustain reductions in metabolic disease risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None