ProteinLOWPRONCT06267235
Dietary Protein Restriction and Health
A study testing Dietary protein restriction in people with Protein and Healthy, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- What is being tested?
- Dietary protein restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI≤25
- Maximal oxygen uptake ≤42-51 ml/kg/min) • non-smoking
Who cannot join
- The use of medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Protein, FGF21 and Glucose Homeostasis
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.
Read the 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 8:00 a.m. in the morning. The participant arrived by car or public transport.
- Being tested
- Dietary protein restriction
- Keywords
- Protein-restriction, FGF21, Energy, Insulin action
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary protein restrictionOther
The consumption of different diets restricted in protein replaced by either carbohydrate or fat and an habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Acute meal test | Experimental | acute intake of a low protein, high carbohydrate diet. No drug intervention Receives: Other: Dietary protein restriction |
| Chronic low protein, high carbohydrate diet | Experimental | Low protein, high carbohydrate diet and habitual diet. No drug intervention Receives: Other: Dietary protein restriction |
| Low protein , high fat diet | Experimental | Low protein, high fat diet and habitual diet. No drug intervention Receives: Other: Dietary protein restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance
Energy balance was measured in an over-night fasted state via indirect calorimetry expressed in MJ/day
prolonged eucaloric dietary protein restriction compared with a higher habitual protein intake
Measured: from week 0 to week 10.
Insulin sensitivity
Insulin sensitivity was measured by the hyperinsulinemic, euglycemic clamp procedure
Measured: Measured at week 5 (low protein, high carbohydrate diet) and week 5 on habitual diet and at week 5 (low protein high fat diet) and week 5 on habitual diet
Secondary outcomes (2)
Adipose tissue proteomics
Mass spectroscopy
Measured: After 5 weeks low protein, high carbohydrate and 5 weeks low protein, high fat. On the tenth week on habitual diet
Plasma FGF21
Measured by Elisa
Measured: Every week from week 0 to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 May 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal study changing diet during the intervention 5 weeks restricted dietary protein + 5 weeks habitual dietary protein consumption
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Kiens, University of Copenhagen
- Investigators
- Bente Kiens, D.sci, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267235
- Sponsor's protocol ID
- lowprotein
- Acronym
- LOWPRO
- Status last verified
- May 2024
- First submitted
- 7 Feb 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Protein, FGF21 and Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT06267235
- Acronym / sponsor ID
- LOWPRO / lowprotein
- Keywords
- Protein-restriction, FGF21, Energy, Insulin action
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 8:00 a.m. in the morning. The participant arrived by car or public transport.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Longitudinal study changing diet during the intervention 5 weeks restricted dietary protein + 5 weeks habitual dietary protein consumption
| Arm | Type | Receives |
|---|---|---|
| Acute meal test | Experimental | Other: Dietary protein restrictionacute intake of a low protein, high carbohydrate diet. No drug intervention |
| Chronic low protein, high carbohydrate diet | Experimental | Other: Dietary protein restrictionLow protein, high carbohydrate diet and habitual diet. No drug intervention |
| Low protein , high fat diet | Experimental | Other: Dietary protein restrictionLow protein, high fat diet and habitual diet. No drug intervention |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI≤25
- Maximal oxygen uptake ≤42-51 ml/kg/min) • non-smoking
Key exclusion criteria (1 listed)
- The use of medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary protein restrictionThe consumption of different diets restricted in protein replaced by either carbohydrate or fat and an habitual diet. | Other | Acute meal test, Chronic low protein, high carbohydrate diet, Low protein , high fat diet |
Primary outcome
Energy balance
Time frame: from week 0 to week 10.
Energy balance was measured in an over-night fasted state via indirect calorimetry expressed in MJ/day prolonged eucaloric dietary protein restriction compared with a higher habitual protein intake
Insulin sensitivity
Time frame: Measured at week 5 (low protein, high carbohydrate diet) and week 5 on habitual diet and at week 5 (low protein high fat diet) and week 5 on habitual diet
Insulin sensitivity was measured by the hyperinsulinemic, euglycemic clamp procedure
2 secondary outcomes
Adipose tissue proteomics
Time frame: After 5 weeks low protein, high carbohydrate and 5 weeks low protein, high fat. On the tenth week on habitual diet
Plasma FGF21
Time frame: Every week from week 0 to week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Kiens, D.sci, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary protein restriction in people with Protein and Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy balance (time frame: from week 0 to week 10.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.