Diabetes Mellitus, Type 2NCT05456347
Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
A study testing Low-calorie and high-protein diet with the majority of protein coming from animal sources. and Low-calorie and high-protein diet with the majority of protein coming from plant sources. in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight and Obesity, PreDiabetes
- What is being tested?
- Low-calorie and high-protein diet with the majority of protein coming from animal sources. and Low-calorie and high-protein diet with the majority of protein coming from plant sources.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 1 Nov 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80.
- BMI between 27.5 kg/m2 and 40 kg/m2.
- Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
- Informed consent to be signed.
Who cannot join
- Taking antidiabetic drugs (except for metformin with stable dose in the previous 6 months).
- Taking lipid-lowering drugs in unstable dose in the previous 2 months.
- Taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight.
- Uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%)
- Any disease that could affect study results (i.e. uncontrolled hypothyroidism).
- Alcohol intake over 30 g/day.
- Pregnancy or breastfeeding.
- Any other condition that investigators consider that could interfere with study outcomes.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, 50009
About this study
Official title: A Randomized Study to Investigate the Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention.
To achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). The study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.
- Being tested
- Low-calorie and high-protein diet with the majority of protein coming from animal sources., Low-calorie and high-protein diet with the majority of protein coming from plant sources.
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-calorie and high-protein diet with the majority of protein coming from animal sources.Behavioural
Diet was prescribed to the participant and menus and recipes were also provided.
Low-calorie and high-protein diet with the majority of protein coming from plant sources.Behavioural
Diet was prescribed to the participant and menus and recipes were also provided.
| Study group | Role | What they receive |
|---|---|---|
| High-protein animal diet. | Experimental | Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein). Receives: Behavioral: Low-calorie and high-protein diet with the majority of protein coming from animal sources. |
| High-protein vegetal diet. | Experimental | Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein). Receives: Behavioral: Low-calorie and high-protein diet with the majority of protein coming from plant sources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose change.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Glycated hemoglobin change.
Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Insulin change.
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
HOMA-IR change.
HOMA-IR change assessed by difference in HOMA-IR concentration (absolute units and %) comparing 3 and 6 months visits with respect to baseline. HOMA-IR is calculated by calculating: [(fasting glucose (mg/dL) x 0,0555) x fasting insulin (UI/ml)] ÷ 22,5.
Measured: After 3 and 6 months of intervention.
Body fat mass change.
Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Fat-free mass change.
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Visceral fat mass change.
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Secondary outcomes (4)
Total cholesterol change.
Total cholesterol change assessed by difference in fasting total cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
LDL cholesterol change.
Total LDL cholesterol change assessed by difference in fasting LDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
HDL cholesterol change.
HDL cholesterol change assessed by difference in fasting HDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Triglycerides change.
Triglycerides change assessed by difference in fasting triglycerides concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Measured: After 3 and 6 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jul 2021
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocio Mateo-Gallego, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456347
- Sponsor's protocol ID
- PI19/485
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodrigo-Carbo C, Madinaveitia-Nisarre L, Perez-Calahorra S, Gracia-Rubio I, Cebollada A, Galindo-Lalana C, Mateo-Gallego R, Lamiquiz-Moneo I. Low-calorie, high-protein diets, regardless of protein source, improve glucose metabolism and cardiometabolic profiles in subjects with prediabetes or type 2 diabetes and overweight or obesity. Diabetes Obes Metab. 2025 Jan;27(1):268-279. doi: 10.1111/dom.16013. Epub 2024 Oct 17.
PubMed 39420528
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Investigate the Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
- ClinicalTrials.gov ID
- NCT05456347
- Acronym / sponsor ID
- PI19/485
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Jul 2022 (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 aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention.
To achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). The study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein animal diet. | Experimental | Behavioral: Low-calorie and high-protein diet with the majority of protein coming from animal sources.Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein). |
| High-protein vegetal diet. | Experimental | Behavioral: Low-calorie and high-protein diet with the majority of protein coming from plant sources.Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80.
- BMI between 27.5 kg/m2 and 40 kg/m2.
- Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
- Informed consent to be signed.
Key exclusion criteria (8 listed)
- Taking antidiabetic drugs (except for metformin with stable dose in the previous 6 months).
- Taking lipid-lowering drugs in unstable dose in the previous 2 months.
- Taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight.
- Uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%)
- Any disease that could affect study results (i.e. uncontrolled hypothyroidism).
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 |
|---|---|---|
| Low-calorie and high-protein diet with the majority of protein coming from animal sources.Diet was prescribed to the participant and menus and recipes were also provided. | Behavioural | High-protein animal diet. |
| Low-calorie and high-protein diet with the majority of protein coming from plant sources.Diet was prescribed to the participant and menus and recipes were also provided. | Behavioural | High-protein vegetal diet. |
Primary outcome
Glucose change.
Time frame: After 3 and 6 months of intervention.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Glycated hemoglobin change.
Time frame: After 3 and 6 months of intervention.
Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.
Insulin change.
Time frame: After 3 and 6 months of intervention.
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 and 6 months visits with respect to baseline.
HOMA-IR change.
Time frame: After 3 and 6 months of intervention.
HOMA-IR change assessed by difference in HOMA-IR concentration (absolute units and %) comparing 3 and 6 months visits with respect to baseline. HOMA-IR is calculated by calculating: [(fasting glucose (mg/dL) x 0,0555) x fasting insulin (UI/ml)] ÷ 22,5.
Body fat mass change.
Time frame: After 3 and 6 months of intervention.
Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.
Fat-free mass change.
Time frame: After 3 and 6 months of intervention.
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.
Visceral fat mass change.
Time frame: After 3 and 6 months of intervention.
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.
4 secondary outcomes
Total cholesterol change.
Time frame: After 3 and 6 months of intervention.
LDL cholesterol change.
Time frame: After 3 and 6 months of intervention.
HDL cholesterol change.
Time frame: After 3 and 6 months of intervention.
Triglycerides change.
Time frame: After 3 and 6 months of intervention.
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 8 Nov 2022.
- Derived from this study: PubMed 39420528Rodrigo-Carbo C, Madinaveitia-Nisarre L, Perez-Calahorra S, Gracia-Rubio I, Cebollada A, Galindo-Lalana C, Mateo-Gallego R, Lamiquiz-Moneo I. Low-calorie, high-protein diets, regardless of protein source, improve glucose metabolism and cardiometabolic profiles in subjects with prediabetes or type 2 diabetes and overweight or obesity. Diabetes Obes Metab. 2025 Jan;27(1):268-279. doi: 10.1111/dom.16013. Epub 2024 Oct 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-calorie and high-protein diet with the majority of protein coming from animal sources. and Low-calorie and high-protein diet with the majority of protein coming from plant sources. in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Universidad de Zaragoza at 1 site in Spain.
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 4 inclusion and 8 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 8 Nov 2022. 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 Spain. 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?
Glucose change. (time frame: After 3 and 6 months of intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456347, which also lists 1 linked publication.
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 8 Nov 2022.