We here study the effect of a 10g/day collagen hydrolysate for a period of 4 weeks on glycemic control and cardiovascular health in a parallel design study using (BMI 25-35 kg/m2) men and women who are likely to have a disturbed lipid and glucose…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men
and women does not change glucose metabolism, as measured by change in average
daily glucose concentrations measured over a 15 hours period between waking up
and going to bed 7:00AM - 22:00PM for three days, which is calculated based on
the total area under the curve (tAUC) over the entire 15 hours follow-up during
these three days
Secondary outcome
To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI
25-35 kg/m2) men and women changes glucose metabolism, lipid metabolism and
low-grade inflammation as measured by:
- Fasting serum lipids and lipoproteins (all blood samples);
- Fasting plasma glucose, insulin, and C-peptide concentrations and calculated
HOMA-IR (all blood samples);
- Fasting low-grade inflammation plasma markers (hsCRP, IL6, IL8, TNFa)
- Postprandial glucose metabolism following a high-fat, high-carb meal;
- Postprandial TAG metabolism following a high-fat, high-carb meal;
To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI
25-35 kg/m2) men and women changes general well being as measured by:
- Quality of life, assessed with a 32-item questionnaire (including social,
spiritual, emotional, cognitive, physical, activities of daily living, and
integrated quality of life),
- Mood, degree of pleasantness and arousal, as assessed with the Affect grid.
- Fatigue as assessed using the FSS, a 9-item questionnaire that is used to
determine the severity of fatigue a subject experienced in the past week during
daily activities
- Cognitive performance, assessed with a validated neuropsychological test
battery (CANTAB)
To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI
25-35 kg/m2) men and women changes vascular function as measured by:
- Venular and arteriolar diameters, assessed via fundus photography;
- Office blood pressure (each visit);
- 36-hour blood pressure profiles using wearables.
-- Cerebral blood flow, assessed using transcranial doppler ultrasound
Background summary
The worldwide incidence of Type 2 Diabetes Mellitus (Type2-DM) is rapidly
growing. People with Type2-DM are at increased risk of developing long-term
micro- and macrovascular complications. Type2-DM accounts for almost one in ten
deaths around the world and up to 80% of these deaths are related to
cardiovascular disease. A functional food ingredient with the ability to
improve glycemic control, which could translate into improved arterial
stiffness, and/or the characteristics of the microcirculation, could
potentially contribute to the delay or prevention of a range of cardiovascular
diseases in the general population and could provide additional complimentary
alternatives to pharmacological and lifestyle based interventions in the
maintenance of cardiovascular health. Food-derived bioactive peptides represent
a source of health-enhancing components that have been reported to have
cardiovascular health benefits in humans and may be incorporated in functional
foods. Up till now studies using collagen hydrolysates particularly addressed
issues around joint health, however there are some preliminary indications that
other health related targets might be affected as well. We here propose to
focus on the potential effects of collagen hydrolysates on glycemic control and
the consequent effects on arterial stiffness and characteristics of the
microcirculation, both important parameters for the assessment of future
cardiovascular disease (CVD) risk.
Study objective
We here study the effect of a 10g/day collagen hydrolysate for a period of 4
weeks on glycemic control and cardiovascular health in a parallel design study
using (BMI 25-35 kg/m2) men and women who are likely to have a disturbed lipid
and glucose metabolism and increased risk to develop CVD and/or Type2-DM.
Study design
During the intervention period, 30 subjects will consume the protein
hydrolysate daily, while another group consumes a placebo (N=30). The primary
outcome parameter of this study is a change in average daily glucose
concentration measured over a 15 hours period between waking up and going to
bed 7:00 AM - 22:00 PM for three consecutive days. Additionally, at the end of
both the experimental periods, a postprandial test will be performed, in which
blood will be sampled frequently (T0, T15, T30, T45, T60, T90, T120, T180, and
T240) to study postprandial glucose and triacylglycerol responses. Finally, we
evaluate changes in perceivable health benefits like the quality of life, mood,
fatigue, cognitive performance and vascular function.
Intervention
During the intervention period, 30 subjects will consume 10 gram collagen
protein hydrolysate daily, while another group consumes a placebo (N=30).
Study burden and risks
Subjects will be screened to determine eligibility during two visits of 15
minutes. During these screening visits, anthropometric measurements will be
performed and blood pressure will be determined. In addition, a venous blood
sample (5.0 mL) will be drawn. During the study there will be 3 separate blood
sampling moments and 2 postprandial test days where also blood is sampled. No
direct health benefit for the study participants is expected. Investigational
products are safe, and all ingredients to prepare the mixed meals for the
postprandial test are commercially available and approved for human
consumption. Sometimes the collagen hydrolysate may cause mild gastrointestinal
discomfort. In total during the entire study 295 mL blood will be sampled (two
screenings of each 5 mL, three times 25 mL fasting, 2 postprandial test days of
105 mL each). Some study subjects may report pain during venipuncture.
Insertion of the cannula can cause some discomfort and possible a hematoma or
bruise. Some subjects may also report pain during the insertion of the cannula.
In principle, all measurements are routine in our metabolic research unit
(MRUM) and are not expected to lead to physical side effects. Time investment
for the participants is approximately 15 hours, excluding travel time.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Aged between 40-75 years - Men and women - BMI between 25-35 kg/m2 - Serum
total cholesterol < 8.0 mmol/L (further testing is recommended for excessive
hyperlipidemia [serum total cholesterol >= 8.0 mmol/L] according to the Standard
for cardiovascular risk management of the Dutch general practitioners community
[NHG]) - Serum triacylglycerol < 4.5 mmol/L - No current smoker - No
diabetic patients - No familial hypercholesterolemia - No abuse of drugs - Not
more than 4 alcoholic consumption per day with a maximum of 21 per week?? -
Stable body weight (weight gain or loss < 3 kg in the past three months) -
No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention
in the previous month - No severe medical conditions that might interfere with
the study, such as epilepsy, asthma, kidney failure or renal insufficiency,
chronic obstructive pulmonary disease, inflammatory bowel diseases, auto
inflammatory diseases and rheumatoid arthritis - No active cardiovascular
disease like congestive heart failure or cardiovascular event, such as an acute
myocardial infarction or cerebrovascular accident - Willingness to give up
being a blood donor from 8 weeks before the start of the study, during the
study and for 4 weeks after completion of the study - No difficult venipuncture
as evidenced during the screening visit - Willing to comply to study protocol
during study - Agree to take porcine / animal derived supplements (i.e.
collagen) - Informed consent signed
Exclusion criteria
- Allergy or intolerance to collagen or collagen hydrolysates - Serum total
cholesterol >= 8.0 mmol/L - Serum triacylglycerol >= 4.5 mmol/L - Current smoker,
or smoking cessation <12 months - Diabetic patients - Familial
hypercholesterolemia - Abuse of drugs - More than 4 alcoholic consumptions per
day or 21 per week - Unstable body weight (weight gain or loss > 3 kg in the
past three months) - Use medication known to treat blood pressure, lipid or
glucose metabolism - Use of an investigational product in another biomedical
intervention within the previous month - Severe medical conditions that might
interfere with the study, such as epilepsy, asthma, kidney failure or renal
insufficiency, chronic obstructive pulmonary disease, inflammatory bowel
diseases, auto inflammatory diseases and rheumatoid arthritis - Active
cardiovascular disease like congestive heart failure or cardiovascular event,
such as an acute myocardial infarction or cerebrovascular accident - Not
willing to give up being a blood donor from 8 weeks before the start of the
study, during the study or for 4 weeks after completion of the study - Not or
difficult to venipuncture as evidenced during the screening visit - Use of
over-the-counter and prescribed medication or supplements, which may interfere
with study measurements to be judged by the principal investigator; - Use of
oral antibiotics in 40 days or less prior to the start of the study; - Blood
donation in the past 3 months before the start of the study - Not willing to
comply to study protocol during study or sign informed consent - Not willing to
consume the collagen hydrolysate because this is from animal origin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72922.068.20 |