Type 2 DiabetesHPBNCT01623648
High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D
A study testing Arm 1 Whey Breakfast, Arm 2 No Whey Breakfast and Arm 3 Low Protein Breakfast in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas at 2 sites in 2 countries.
Trial summary
The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Arm 1 Whey Breakfast, Arm 2 No Whey Breakfast and Arm 3 Low Protein Breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2013to Oct 2016
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥30 and ≤70 years of age
- BMI: 26 to 34 kg/m2)
- Diabetes criteria
- HbA1C: 7-9 % or
- Habitually eat breakfast
- Only naïve or treated with metformin.
Show all 10Show fewer
- Those with anti-hypertensive and lipid-lowering medication will be included.
- . Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
- 10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation.
- 12. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m2.
Who cannot join
- Type 1 Diabetes
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- Anemia (Hg > 10 g/dL)
- Serum creatinine level < 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
Show all 13Show fewer
- Infectious disease
- Malignancy
- Pregnant women or lactating
- Known hypersensitivity to milk components
- 10. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
- 12. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals
Read the detailed description
Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression.
However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals.
To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals
- Conditions
- Type 2 Diabetes
- Being tested
- Arm 1 Whey Breakfast, Arm 2 No Whey Breakfast, Arm 3 Low Protein Breakfast
- Keywords
- whey protein, hunger
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Whey BreakfastOther
Also called Whey
The patients will be assigned to eat 42 g protein namely from Whey protein in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
Arm 2 No Whey BreakfastOther
Also called No Whey
The patients will be assigned to eat 42 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
Arm 3 Low Protein BreakfastOther
Also called Low Protein
The patients will be assigned to eat 22 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Whey Breakfast | Experimental | The arm 1 will be assigned to eating Whey protein in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein namely from whey at breakfast Receives: Other: Arm 1 Whey Breakfast |
| Arm 2: No Whey Breakfast | Active comparator | The arm 2 will be assigned to intake other proteins (No Whey) in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein from other sources at breakfast Receives: Other: Arm 2 No Whey Breakfast |
| Arm 3: Low Protein Breakfast | Placebo comparator | The arm 3 will be assigned to intake low protein and high carbohydrate breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 22 g protein from other sources at breakfast Receives: Other: Arm 3 Low Protein Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Postprandial plasma glucose after breakfast, lunch and dinner
Measured: 12 weeks
Secondary outcomes (4)
Plasma Insulin
Postprandial plasma insulin after breakfast lunch and dinner
Measured: 12 weeks
Hunger
Postprandial Hunger after breakfast lunch and dinner, assessed with visual analog scale.
Measured: 12 weeks
Satiety
Postprandial Satiety after breakfast lunch and dinner, assessed with visual analog scale.
Measured: 12 weeks
Change in body weight
Body weight will be assessed every every two weeks until week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas Caracas
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Hospital de Clinicas Caracas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623648
- Sponsor's protocol ID
- HCCCBI 017-2007-104
- Acronym
- HPB
- Status last verified
- Jul 2016
- First submitted
- 18 Jun 2012
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein vs Other Proteins in the Breakfast on Appetite, Overall Postprandial Glycemia and Weight Loss, in Obese Diabetic Individuals
- ClinicalTrials.gov ID
- NCT01623648
- Acronym / sponsor ID
- HPB / HCCCBI 017-2007-104
- Conditions
- Type 2 Diabetes
- Keywords
- whey protein, hunger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hospital de Clinicas CaracasUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Feb 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 20 Jun 2012 (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 investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals
Detailed description
Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression.
However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals.
To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Whey Breakfast | Experimental | Other: Arm 1 Whey BreakfastThe arm 1 will be assigned to eating Whey protein in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein namely from whey at breakfast |
| Arm 2: No Whey Breakfast | Active comparator | Other: Arm 2 No Whey BreakfastThe arm 2 will be assigned to intake other proteins (No Whey) in the breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 42 g protein from other sources at breakfast |
| Arm 3: Low Protein Breakfast | Placebo comparator | Other: Arm 3 Low Protein BreakfastThe arm 3 will be assigned to intake low protein and high carbohydrate breakfast (660 kcal), lunch (560 cal) and dinner (280 cal), with 22 g protein from other sources at breakfast |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects ≥30 and ≤70 years of age
- BMI: 26 to 34 kg/m2)
- Diabetes criteria
- HbA1C: 7-9 % or
- Habitually eat breakfast
Key exclusion criteria (13 listed)
- Type 1 Diabetes
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- Anemia (Hg > 10 g/dL)
- Serum creatinine level < 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
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 |
|---|---|---|
| Arm 1 Whey BreakfastAlso: WheyThe patients will be assigned to eat 42 g protein namely from Whey protein in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal) | Other | Arm 1 Whey Breakfast |
| Arm 2 No Whey BreakfastAlso: No WheyThe patients will be assigned to eat 42 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal) | Other | Arm 2: No Whey Breakfast |
| Arm 3 Low Protein BreakfastAlso: Low ProteinThe patients will be assigned to eat 22 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal) | Other | Arm 3: Low Protein Breakfast |
Primary outcome
Plasma glucose
Time frame: 12 weeks
Postprandial plasma glucose after breakfast, lunch and dinner
4 secondary outcomes
Plasma Insulin
Time frame: 12 weeks
Hunger
Time frame: 12 weeks
Satiety
Time frame: 12 weeks
Change in body weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Daniela Jakubowicz, MD principal investigator
Hospital de Clinicas Caracas
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 Whey Breakfast, Arm 2 No Whey Breakfast and Arm 3 Low Protein Breakfast in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas at 2 sites in 2 countries.
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 10 inclusion and 13 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Venezuela. 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. Some participants in this study may receive a placebo. 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?
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?
Plasma glucose (time frame: 12 weeks). 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 6 Jul 2016.