Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

NCT ID: NCT02954588

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-14
• Study Completion Date: 2020-08-08

Brief Summary

A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance.

The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons.

A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.

Conditions

Abdominal Obesity Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Pyridoxamine (1)

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks.

Group Type: ACTIVE_COMPARATOR

Pyridoxamine

Intervention Type: DIETARY_SUPPLEMENT

Pyridoxamine (2)

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks

Group Type: ACTIVE_COMPARATOR

Pyridoxamine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Pyridoxamine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Abdominal obesity: Waist circumference for men should be above 102 cm and for women above 88 cm.
• Caucasian (because of skin fluorescence and capillary microscopy measurements)
• Aged 18-75 years

Exclusion Criteria

• Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
• Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
• Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
• Smoking (>10 cigarettes per day)
• High alcohol usage (>4 U/day) or drug abuse
• Use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, NSAID's)
• Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
• Known allergic reaction to ultrasound contrast-agent
• Pulmonary or inflammatory disease
• Kidney failure or electrolyte disorders
• Use of dietary supplements or an investigational product within the previous month
• Unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss >3 kg in the last two months)
• Pregnancy or lactation
• No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
• Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study
• Insufficient knowledge of the Dutch language

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Top Institute Food and Nutrition

OTHER

Sponsor Role: collaborator

Center for Translational Molecular Medicine

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Casper G Schalkwijk, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

References

Van den Eynde MDG, Scheijen JLJM, Stehouwer CDA, Miyata T, Schalkwijk CG. Quantification of the B6 vitamers in human plasma and urine in a study with pyridoxamine as an oral supplement; pyridoxamine as an alternative for pyridoxine. Clin Nutr. 2021 Jul;40(7):4624-4632. doi: 10.1016/j.clnu.2021.05.028. Epub 2021 Jun 10.

Reference Type: DERIVED

PMID: 34229268 (View on PubMed)

Other Identifiers

NL51023.068.16

Identifier Type: -

Identifier Source: org_study_id