Metabolism of Anthocyanins and Heart Health
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
The primary aim of this cross-over designed, placebo controlled, acute dietary intervention study, is to prospectively recruit participants on the basis of anthocyanin metabolism profiles (based on profiles confirmed in our previous studies) following a 'blueberry challenge'. Acute cardio and metabolic function responses will be assessed (by metaboliser profile), following an energy dense test meal with/without the addition of blueberries.
Participants will be healthy, but overweight and obese (BMI inclusion: ≥ 25kg/m2) men and women (aged 50 y to 80 y), who will initially undertake a 'blueberry challenge' by consuming a single dose of freeze dried blueberries. Anthocyanin metaboliser type will be profiled from the analysis of metabolites within urine, collected for 48h following the 'challenge'.
A total of 70 participants will complete the intervention (n=35 FAST and n=35 SLOW metabolisers) which consists of two, test meal periods (separated by at least 7d and allocated in random order); 1) energy dense test meal plus freeze dried blueberries, 2) energy dense test meal plus an isocaloric matched placebo material. Urine samples and ambulatory blood pressure measures will be collected for 24h prior to, and then over the 48h period which follows the test meal intake. Further assessment of vascular and metabolic function will be made at pre-defined times over the 48h postprandial period. Dietary restrictions to abstain from blueberries and reduce the anthocyanin intake level, will be applied for 5d before each test meal intake. In addition, all food and drink will be provided for a 4d period (2d before and during the 48h following the energy dense test meal) to further control the intake of flavonoids and to standardise the influence of background diet on metabolism profile.
Ημερομηνίες
| Τελευταία επαλήθευση: | 08/31/2019 |
| Πρώτα υποβλήθηκε: | 03/03/2019 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 03/06/2019 |
| Δημοσιεύτηκε για πρώτη φορά: | 03/10/2019 |
| Υποβλήθηκε τελευταία ενημέρωση: | 09/23/2019 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 09/25/2019 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 06/03/2019 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 08/31/2020 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 11/30/2020 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Other: Freeze dried blueberry powder
Other: Anthocyanin free, sugar-matched placebo
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: SLOW anthocyanin metabolisers Participants will be prospectively recruited to the SLOW anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. | |
| Experimental: FAST anthocyanin metabolisers Participants will be prospectively recruited to the FAST anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 50 Years Προς την 50 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - BMI >= 25 kg/m2 - Adults aged 50 - 80 years old - Successful biochemical, haematological, and urinalysis assessment at screening Exclusion Criteria: - Current smokers, or ex-smokers ceasing < 6 months ago - existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures - Fructose or lactose intolerant subjects or known allergies to intervention treatments - Those unprepared to adhere to dietary instructions - Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material - Those on therapeutic diets or having experienced substantial weight loss within 2 months of screening. - Those taking flavonoid, nitrate / nitrite containing or fish oil containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements. - Prescribed hypoglycaemic, anti-hypertensive, vasodilator or hormone replacement therapy (HRT) medication. - Unsatisfactory biochemical, haematological or urinary results or measurements considered to be counter indicative for the study - Undiagnosed hypertension (elicited at screening; i.e. ≥ 180 / 110mmHg) at a level requiring immediate referral back to general practitioner for follow-up |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Brachial artery endothelial function [assessed at 0, 1.5, 3, 6, 24, 48 hours after intervention intake]
Δευτερεύοντα αποτελέσματα
1. Office blood pressure [Assessed at 0, 3, 6, 24, 48 hours after intervention intake.]
2. Bioavailability - serum [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
3. Postprandial Insulin response [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
4. Total cholesterol [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
Άλλα μέτρα αποτελεσμάτων
1. Microbiome assessment of phyla and species [Sample collected up to 2 days prior to test meal 1 and assessed within 5 years of study completion]
2. Ambulatory blood pressure [1 day before, and the two days following the intake of each energy dense test meal]
3. Aortic arterial stiffness (cf-PWV) [assessed at 0, 3, 6, 24, 48 hours after intervention intake]
4. Systemic arterial stiffness (AIx) [assessed at 0, 3, 6, 24, 48 hours after intervention intake]
5. Bioavailability - urine [3 days during the blueberry challenge (1 day before and the two days of the assessment) and 3 days during each test meal assessment (1 day before and the two days of the assessment)]
6. Postprandial glucose response [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
7. High density lipoprotein cholesterol [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
8. Triglycerides [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
9. Low density lipoprotein cholesterol [Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.]
