Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518930
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2020-08-15
Brief Title:
High Fat vs High Protein and Appetite Hormones
Sponsor:
Al-Balqa Applied University
Organization:
Al-Balqa Applied University
Study Overview
Official Title:
Comparing the Effect of High-Fat Peanuts Versus High-Protein Plain Greek Yogurt Snacks on Appetite Hormones and Satiety Among Overweight and Obese Women
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This study will investigate the effects of high-protein high-fat snacks specifically Greek yogurt and peanuts on satiety gut hormones and insulin secretion in overweight and obese women The hypothesis posited that peanuts will exhibit a more beneficial impact on satiety gut hormones and insulin levels compared to Greek yogurt The two-arm parallel randomized trial will involve 52 participants aged 30 to 40 with a BMI between 25-35 kgm²and they will be randomly divided into peanut n26 and Greek yogurt n26 groups Pre-snack BMI and dietary intake will be assessed Appetite sensations will be gauged using a visual analog scale VAS upon arrival and at 30- and 60-minutes post-snack Pre- and post-snacking plasma levels of cholecystokinin CCK Peptide Tyrosine-Tyrosine PYY Glucagon Like Peptide-1 GLP-1 Ghrelin GHRL and insulin will be analyzed
Detailed Description:
The studys inclusion criteria will be encompassed women aged between 30 and 40 years with a body mass index BMI ranging from 25 to 35 kgm² These individuals engaged in light exercise 1-3 times per week activity factor 1375 and adhered to a routine of consuming three regular meals along with two daily snacks and maintaining a water intake of eight cups and do not have allergies to nuts or yogurt
All participants should adhere to a 1200 kcal diet plan which included breakfast snack 1 lunch snack 2 and dinner This diet plan will remain consistent for all participants over a consecutive three-day period except for the snacks that will be provided during the second visit The specific snack assigned to each participant will be determined based on a predetermined randomization list The first experimental group n26 will receive a high-protein snack in the form of plain Greek yogurt while the second experimental group n26 will receive a high-fat snack in the form of peanuts
Prior to intervention in the first visit all anthropometric and body composition assessments will be performed On the second visit which will be scheduled after three days of adhering to the 1200 Kcal diet all participants should arrive at the clinic at 100 pm and they should had their breakfast at home at 900 am Upon arrival a baseline blood samples from each participant will be collected
At 100 pm participants in the plain Greek yogurt and peanut groups will consume their assigned snacks Following snack consumption a validated visual analog scale VAS questionnaire will be distributed to assess sensations and appetite levels at 0 minutes 100 pm 30 minutes 130 pm and 60 minutes 200 pm
One hour after their arrival at 200 pm a second blood sample will be collected from all participants Serum samples will be used to analyze the Ghrelin PYY CCK Glp-1 and insulin using human ELISA kits
Statistical analysis will be performed after data entry using the SPSS statistical software Prior to analysis data will be tested for normality Descriptive statistics for continuous means SD and categorical variables frequencies and percentages along with analytical statistics including t-test for paired and unpaired means and the repeated measures for the general linear model will be performed too P 005 will consider significant
All participants should adhere to a 1200 kcal diet plan which included breakfast snack 1 lunch snack 2 and dinner This diet plan will remain consistent for all participants over a consecutive three-day period except for the snacks that will be provided during the second visit The specific snack assigned to each participant will be determined based on a predetermined randomization list The first experimental group n26 will receive a high-protein snack in the form of plain Greek yogurt while the second experimental group n26 will receive a high-fat snack in the form of peanuts
Prior to intervention in the first visit all anthropometric and body composition assessments will be performed On the second visit which will be scheduled after three days of adhering to the 1200 Kcal diet all participants should arrive at the clinic at 100 pm and they should had their breakfast at home at 900 am Upon arrival a baseline blood samples from each participant will be collected
At 100 pm participants in the plain Greek yogurt and peanut groups will consume their assigned snacks Following snack consumption a validated visual analog scale VAS questionnaire will be distributed to assess sensations and appetite levels at 0 minutes 100 pm 30 minutes 130 pm and 60 minutes 200 pm
One hour after their arrival at 200 pm a second blood sample will be collected from all participants Serum samples will be used to analyze the Ghrelin PYY CCK Glp-1 and insulin using human ELISA kits
Statistical analysis will be performed after data entry using the SPSS statistical software Prior to analysis data will be tested for normality Descriptive statistics for continuous means SD and categorical variables frequencies and percentages along with analytical statistics including t-test for paired and unpaired means and the repeated measures for the general linear model will be performed too P 005 will consider significant
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