Weight LossNCT02559479
A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
A study testing Weight loss interventional study with a low-calorie 18%-protein diet and Weight loss interventional study with a low-calorie 35%-protein diet in people with Weight Loss and Obesity, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
Trial summary
The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Weight Loss, Obesity, Diabetes
- What is being tested?
- Weight loss interventional study with a low-calorie 18%-protein diet and Weight loss interventional study with a low-calorie 35%-protein diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Jun 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years old.
- Body mass index between 27.5 - 40.
- Steady weight (± 4 kg) in the last 2 months.
- Glycated hemoglobin between 6 - 7%.
Who cannot join
- Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.
- Lipid-lowering drugs in the last 2 months.
- Gouty arthritis in the last 2 years or uric acid > 735 mg/dl.
- Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- Hepatic chronic disease (glomerular filtration rate < 45 ml/min).
- Renal, inflammatory or tumoral diseases.
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- Drugs which could interfere in glucose or lipid metabolism such as androgens, corticosteroids (except for those with topic administration) and estrogen replacement therapy.
- Intake of functional foods with plant sterols in the past 6 weeks.
- High alcohol intake (> 30 g per day).
- Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
- Pregnancy or intention of pregnancy during the study.
Trial locations and contacts
1 site in 1 country.
Rocio Mateo-Gallego, RD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Fernando Civeira
Zaragoza, Zaragoza, 50009
Rocio Mateo-Gallego, RD, PhD, +34 976765500 ext. 2895, rmateo.iacs@aragon.es
Victoria Marco-Benedí, RD, +34 976765500 ext. 2895, vito2911@hotmail.com
About this study
The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.
- Conditions
- Weight Loss, Obesity, Diabetes, Diet, Reducing, Carbohydrates, Protein
- Being tested
- Weight loss interventional study with a low-calorie 18%-protein diet, Weight loss interventional study with a low-calorie 35%-protein diet
- Medical subject headings
- Weight Loss, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss interventional study with a low-calorie 18%-protein dietBehavioural
Weight loss interventional study with a low-calorie 35%-protein dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 18%-Protein diet | Active comparator | Energy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates Receives: Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet |
| 35%-Protein diet | Active comparator | Energy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates Receives: Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose.
Measured: After 3 and 6 months of intervention.
Change in glycated hemoglobin.
Measured: After 3 and 6 months of intervention.
Change in insulin resistance (HOMA index).
Measured: After 3 and 6 months of intervention.
Secondary outcomes (4)
Change in body weight.
Measured: After 3 and 6 months of intervention.
Change in body composition.
Measured: After 3 and 6 months of intervention.
Change in waist circumference.
Measured: After 3 and 6 months of intervention.
Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).
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 posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
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 Weight LossStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Civeira, Instituto Aragones de Ciencias de la Salud
- Investigators
- Fernando Civeira, MD, PhD, Principal investigator, Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559479
- Sponsor's protocol ID
- CEICA;PI/15/0183
- Status last verified
- Dec 2016
- First submitted
- 22 Sep 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Marco-Benedi V, Perez-Calahorra S, Bea AM, Lamiquiz-Moneo I, Baila-Rueda L, Cenarro A, Civeira F, Mateo-Gallego R. High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity. Clin Nutr. 2020 May;39(5):1354-1363. doi: 10.1016/j.clnu.2019.06.005. Epub 2019 Jun 15.
PubMed 31255349
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
- ClinicalTrials.gov ID
- NCT02559479
- Acronym / sponsor ID
- CEICA;PI/15/0183
- Conditions
- Weight Loss, Obesity, Diabetes, Diet, Reducing, Carbohydrates, Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- 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 objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18%-Protein diet | Active comparator | Behavioral: Weight loss interventional study with a low-calorie 18%-protein dietEnergy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates |
| 35%-Protein diet | Active comparator | Behavioral: Weight loss interventional study with a low-calorie 35%-protein dietEnergy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-70 years old.
- Body mass index between 27.5 - 40.
- Steady weight (± 4 kg) in the last 2 months.
- Glycated hemoglobin between 6 - 7%.
Key exclusion criteria (11 listed)
- Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.
- Lipid-lowering drugs in the last 2 months.
- Gouty arthritis in the last 2 years or uric acid > 735 mg/dl.
- Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- Hepatic chronic disease (glomerular filtration rate < 45 ml/min).
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 |
|---|---|---|
| Weight loss interventional study with a low-calorie 18%-protein diet | Behavioural | 18%-Protein diet |
| Weight loss interventional study with a low-calorie 35%-protein diet | Behavioural | 35%-Protein diet |
Primary outcome
Change in glucose.
Time frame: After 3 and 6 months of intervention.
Change in glycated hemoglobin.
Time frame: After 3 and 6 months of intervention.
Change in insulin resistance (HOMA index).
Time frame: After 3 and 6 months of intervention.
4 secondary outcomes
Change in body weight.
Time frame: After 3 and 6 months of intervention.
Change in body composition.
Time frame: After 3 and 6 months of intervention.
Change in waist circumference.
Time frame: After 3 and 6 months of intervention.
Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).
Time frame: After 3 and 6 months of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Derived from this study: PubMed 31255349Marco-Benedi V, Perez-Calahorra S, Bea AM, Lamiquiz-Moneo I, Baila-Rueda L, Cenarro A, Civeira F, Mateo-Gallego R. High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity. Clin Nutr. 2020 May;39(5):1354-1363. doi: 10.1016/j.clnu.2019.06.005. Epub 2019 Jun 15.
- Individual participant dataSharing planned: Yes
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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.
Rocio Mateo-Gallego, RD, PhD contact
Fernando Civeira, MD, PhD principal investigator
Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss interventional study with a low-calorie 18%-protein diet and Weight loss interventional study with a low-calorie 35%-protein diet in people with Weight Loss and Obesity, run by Instituto Aragones de Ciencias de la Salud 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 11 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: status not confirmed, as of the sponsor's last update on 2 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Civeira, MD, PhD (+34 976765500 ext. 2884, civeira@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose. (time frame: After 3 and 6 months of intervention.). The study lists 3 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 NCT02559479, 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 2 Dec 2016.