Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06267235 |
Other study ID # |
lowprotein |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2018 |
Est. completion date |
January 31, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of Copenhagen |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 1.5 g/kg/day, which is at the high end of the recommendations (0.8-1.5
g/kg/day) 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 (0.9 g/kg/day), compared to the participants
usual diet (1.5 g/kg/day), 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.
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 8:00 a.m. in the morning. The participant arrived by car or public transport.