E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 vaccination respons of people with BMI 27-35 kg/m2 |
COVID-19 vaccinatierespons van mensen met een BMI tussen 27-35 kg/m2 |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 vaccination respons of people with overweight or obesity |
COVID-19 vaccinatierespons van mensen met overgewicht of obesitas |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients aged 18 years or older. |
Het aantonen van klinische voordelen van inname van plantenstanolen op de COVID-19 vaccinatierespons |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of plant stanol esters on metabolic parameters (e.g. glucose, insulin, blood lipid and lipoprotein profile). 2. To evaluate the effect of plant stanol esters on hematological and immunological parameters (e.g. leukocyte differential count, hsCRP, cytokine production by stimulated PBMCs)
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Het evaluaren van de effecten van plantenstanolen op 1. metabole parameters en 2. hemotologische en immunologische uitkomsten |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Men and women • Aged 18 years or older • BMI between 27 and 35 kg/m2 • Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) • Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) • Willing to keep the intake of fish oil and vitamin supplements constant
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Mannen en vrouwen, 18 jaar of ouder, BMI 27-35 kg/m2, gebruikt geen producten met toegevoegde plantensterolen of plantenstanolen, zal geen producten met toegevoegde plantensterolen of plantenstanolen gebruiken tijdens het onderzoek, zal inname visolie en vitaminesupplementen constant houden tijdens onderzoek |
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E.4 | Principal exclusion criteria |
Already received COVID-19 vaccination, already had a positive test for COVID-19 (all tests, e.g. PCR test or antibody test), allergy to an ingredient of the mini drinks, excessive alcohol use (>20 consumptions per week), regular use of drugs, blood donors that want to donate one month prior to or during the study, pregnant or breastfeeding women |
COVID-19 vaccinatie al gehad, ooit een positieve COVID-19 test gehad (alle tests, bijv. PCR test of antistoffen test), allergisch voor een ingrediënt van de studieproducten, overmatig alcoholgebruik (>20 glazen per week), regelmatig gebruik van drugs, bloeddonoren die in de maand voorafgaand aan het onderzoek of tijdens het onderzoek doneren, vrouwen die zwanger zijn of borstvoeding geven |
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E.5 End points |
E.5.1 | Primary end point(s) |
COVID-19 vaccination specific antibody response (IgG, IgM) |
COVID-19 vaccinatierespons (vaccin specifieke antilichamen) (IgG, IgM) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Two times prior to the vaccination, four times following the month after vaccination |
Twee keer voor de vaccinatie en vier keer in de maand na de vaccinatie |
|
E.5.2 | Secondary end point(s) |
• Cytokine concentrations by stimulated PBMCs • Plasma markers for inflammation (hsCRP) • Hematology (leukocyte count, leukocyte differential count) • Serum plant stanol concentrations (sitostanol, campestanol) for compliance • Serum lipid and lipoprotein profile (TC, HDL-C, LDL-C, TAG) • Serum non-cholesterol sterols which are markers for intestinal cholesterol absorption (sitosterol, campesterol, cholestanol) or endogenous synthesis (lathosterol, desmosterol) • Plasma glucose, serum insulin concentrations and (calculated) HOMA-IR • Anthropometry (body weight, waist circumference, waist to hip ratio, height, BMI)
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cytokines geproduceerd door PBMCs, hsCRP, leukocyten (differentiaal) telling, planten sterolen en stanolen in serum, serum lipiden en lipoproteinen, plasma glucose, serum insuline, HOMA-IR, antropometrie |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Two times prior to the vaccination, four times in the month following vaccination |
Twee keer voor de vaccinatie en vier keer in de maand na de vaccinatie |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last subject undergoing the trial |
Laatste deelnemer die het onderzoek afrond |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |