Metabolic SyndromeNCT02087124
Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome
A study testing Whey protein in people with Metabolic Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Cardiovascular disease (CVD) is one of the most important and frequent causes of death. Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jun 2014
- 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
- Central obesity (female > 80 cm; male > 94 cm) with two of the following parameters:
- Fasting triglycerides > 1.7 mmol/L
- Fasting HDL-cholesterol < 1.03 mmol/L (female) or <1.29 mmol/L (male)
- Blood pressure ≥ 130/85 mmHg
- Fasting plasma glucose ≥ 5.6 mmol/L Subjects who are in medical treatment with lipid and/or blood pressure-lowering habitual treatment can participate provided that the treatment is stable throughout the trial.
Who cannot join
- Type 1 diabetes
- Type 2 diabetes (HbA1c ≥ 48 mmol/L)
- Fasting plasma triglycerides > 5.0 mmol/L
- Blood pressure > 160/100 mmHg
- Cardiovascular, liver, kidney or metabolic disease
- Corticosteroid treatment
Show all 9Show fewer
- Pregnancy or lactation
- Alcohol or drug abuse
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whey Protein, Postprandial Lipaemia and Cardiovascular Disease: Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipaemia in Persons With the Metabolic Syndrome and Type 2 Diabetes
Cardiovascular disease (CVD) is one of the most important and frequent causes of death. Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2 diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal. Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D. Identification of a simple diet-related method will possibly result in reduction of CVD in healthy as well as high-risk subjects.
The aim of this project is to investigate if there is a dose-response effect of whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and metabolomics. Also satiety feeling will be measured.
Read more
Investigators hypothesize that whey protein (10 or 20g) consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a dose-dependent way compared to placebo (water) consumed prior to the meal in subjects with MeS.
The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner. It will promote innovation to the food industry for development and production of healthy food products, which can be applied in the fight against CVD in the background population in general and high-risk people in particular. Thus, the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems.
Read the detailed description
Using a randomised, cross-over design 20 subjects with MeS will consume a test meal prior to a fat-rich meal. The test meals contain three different amounts of whey protein. Blood samples are collected before consumption of the pre-meal and after consumption of the fat-rich isocaloric meal during 360 minutes. The fat-rich isocaloric meal is a breakfast containing 1043 kcal (15 E% protein, 65 E% fat and 20 E% carbohydrates). The main-meal is composed of white bread, rye bread, butter, cheese (45 %), salami, egg, bacon, milk (1.5 % fat) and coffee (decaffeinated) and should be consumed over 15 min. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling.
- Conditions
- Metabolic Syndrome
- Being tested
- Whey protein
- Keywords
- Whey protein, Postprandial lipaemia, Pre-meal, Metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinOther
Also called Brand name: LACPRODAN® SP-9225 Instant, Lot nr.: D150214
Different amounts of whey protein dissolved in 200 mL water.
| Study group | Role | What they receive |
|---|---|---|
| 0g whey protein | Experimental | 0g whey protein dissolved in 200 milliliter (mL) water. Receives: Other: Whey protein |
| 10g whey protein | Experimental | 10g whey protein dissolved in 200 milliliter (mL) water. Receives: Other: Whey protein |
| 20g whey protein | Experimental | 20g whey protein dissolved in 200 milliliter (mL) water. Receives: Other: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response of whey protein as pre-meal on triglycerides after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.
Dose-response of whey protein as pre-meal on apolipoprotein B48 after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
Secondary outcomes (5)
Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Measured: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Ann Overgaard, Aarhus University Hospital
- Investigators
- Kjeld Hermansen, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087124
- Sponsor's protocol ID
- CERN-Premeal1
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein, Postprandial Lipaemia and Cardiovascular Disease: Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipaemia in Persons With the Metabolic Syndrome and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02087124
- Acronym / sponsor ID
- CERN-Premeal1
- Conditions
- Metabolic Syndrome
- Keywords
- Whey protein, Postprandial lipaemia, Pre-meal, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Mar 2014 (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.
Cardiovascular disease (CVD) is one of the most important and frequent causes of death. Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2 diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal. Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D. Identification of a simple diet-related method will possibly result in reduction of CVD in healthy as well as high-risk subjects.
The aim of this project is to investigate if there is a dose-response effect of whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and metabolomics. Also satiety feeling will be measured.
Investigators hypothesize that whey protein (10 or 20g) consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a dose-dependent way compared to placebo (water) consumed prior to the meal in subjects with MeS.
The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner. It will promote innovation to the food industry for development and production of healthy food products, which can be applied in the fight against CVD in the background population in general and high-risk people in particular. Thus, the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems.
Detailed description
Using a randomised, cross-over design 20 subjects with MeS will consume a test meal prior to a fat-rich meal. The test meals contain three different amounts of whey protein. Blood samples are collected before consumption of the pre-meal and after consumption of the fat-rich isocaloric meal during 360 minutes. The fat-rich isocaloric meal is a breakfast containing 1043 kcal (15 E% protein, 65 E% fat and 20 E% carbohydrates). The main-meal is composed of white bread, rye bread, butter, cheese (45 %), salami, egg, bacon, milk (1.5 % fat) and coffee (decaffeinated) and should be consumed over 15 min. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0g whey protein | Experimental | Other: Whey protein0g whey protein dissolved in 200 milliliter (mL) water. |
| 10g whey protein | Experimental | Other: Whey protein10g whey protein dissolved in 200 milliliter (mL) water. |
| 20g whey protein | Experimental | Other: Whey protein20g whey protein dissolved in 200 milliliter (mL) water. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Central obesity (female > 80 cm; male > 94 cm) with two of the following parameters:
- Fasting triglycerides > 1.7 mmol/L
- Fasting HDL-cholesterol < 1.03 mmol/L (female) or <1.29 mmol/L (male)
- Blood pressure ≥ 130/85 mmHg
- Fasting plasma glucose ≥ 5.6 mmol/L Subjects who are in medical treatment with lipid and/or blood pressure-lowering habitual treatment can participate provided that the treatment is stable throughout the trial.
Key exclusion criteria (9 listed)
- Type 1 diabetes
- Type 2 diabetes (HbA1c ≥ 48 mmol/L)
- Fasting plasma triglycerides > 5.0 mmol/L
- Blood pressure > 160/100 mmHg
- Cardiovascular, liver, kidney or metabolic disease
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 |
|---|---|---|
| Whey proteinAlso: Brand name: LACPRODAN® SP-9225 Instant, Lot nr.: D150214Different amounts of whey protein dissolved in 200 mL water. | Other | 0g whey protein, 10g whey protein, 20g whey protein |
Primary outcome
Dose-response of whey protein as pre-meal on triglycerides after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.
Dose-response of whey protein as pre-meal on apolipoprotein B48 after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
5 secondary outcomes
Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time frame: Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
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 21 Jul 2014.
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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.
Kjeld Hermansen, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein in people with Metabolic Syndrome, run by Aarhus University Hospital 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 5 inclusion and 9 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 21 Jul 2014. 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?
Dose-response of whey protein as pre-meal on triglycerides after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min) (time frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.). 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 21 Jul 2014.