Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267235
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-02-07
Brief Title:
Dietary Protein Restriction and Health
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Dietary Protein FGF21 and Glucose Homeostasis
Status:
COMPLETED
Status Verified Date:
2024-05
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:
LOWPRO
Brief Summary:
The incidence of type 2 diabetes worldwide has increased significantly over the past decades which is associated with changing dietary habits and physical inactivity According to the diet so far there has been a great focus on the quality of carbohydrates and fat in relation to metabolic health while the importance of protein has been neglected The Danes average protein intake is 15 gkgday which is at the high end of the recommendations 08-15 gkgday from the Nordic Nutrition Recommendations NNR 2023 Recent studies in rodents have shown that protein restriction has positive effects on health including improved glucose and insulin homeostasis and reduced fat mass while a high intake of protein has a negative effect on insulin sensitivity Previously the investigators have shown in healthy young men that consuming a diet low in protein 09 gkgday compared to the participants usual diet 15 gkgday over 7 days resulted in an increased insulin sensitivity as well as a marked increase in the plasma fibroblast growth factor 21 FGF21 concentration The increased insulin sensitivity is thought to be mediated by the increase in plasma FGF21 concentration However the effect is not yet fully understood It is also not clear whether the increase in plasma FGF21 concentration as well as the mentioned metabolic effects on insulin and glucose homeostasis will take place if the participants are kept weight stable on a eucaloric diet
Detailed Description:
A three-arm protocol was performed In protocol 1 participants ingested either a low-protein LP meal or a higher protein HP meal in a randomized order separated by 72 h followed by a 5-week low-protein high-carbohydrate LPHC diet In protocol 2 and 3 participants ingested either a LPHC diet or a low-protein high-fat LPHF diet for 5 weeks followed by a higher protein diet HPD for another 5 weeks All diets were eucaloric Resting metabolic rate RMR was measured pre during and post the protein-restricted interventions A hyperinsulimic-euglycemic clamp was performed post the protein-restricted interventions and post the HPD interventions A basal subcutaneous abdominal fat biopsy was obtained post the protein-restricted interventions and post the HPD interventions In a run-in period over 14 days the participant records the daily number of steps and physical activity in order to determine their habitual activity level During this period a 4-day dietary record is performed where all ingested food was weighed and recorded During the experimental period the participant followed the supplied diet All food consumed during the interventions was handed out to the subject at the institute All food was packaged and weighed to 1 gram of accuracy During the dietary intervention a weekly test in the morning was performed where the resting metabolic rate was measured and blood samples taken from the arm vein At week 0 5 and week 10 body composition was measured by dual energy x-ray absorptiometry scanning DXA and the fat biopsy was obtained At all tests participants arrived fasting at the institute at 800 am in the morning The participant arrived by car or public transport
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