Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

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StatusMerekrut

Sponsor

University of Central Lancashire

UJI KLINIS: NCT04177238

BioSeek: nct04177238

Kata kunci

Abstrak

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.

tanggal

Terakhir Diverifikasi:	01/31/2020
Pertama Dikirim:	11/20/2019
Perkiraan Pendaftaran Telah Dikirim:	11/21/2019
Pertama Diposting:	11/25/2019
Pembaruan Terakhir Dikirim:	02/09/2020
Pembaruan Terakhir Diposting:	02/11/2020
Tanggal Mulai Studi Sebenarnya:	01/20/2020
Perkiraan Tanggal Penyelesaian Utama:	07/04/2021
Perkiraan Tanggal Penyelesaian Studi:	08/04/2021

Kondisi atau penyakit

Metabolic Syndrome

Intervensi / pengobatan

Dietary Supplement: Fruit concentrate - either cherry or blueberry

Tahap

Kelompok Lengan

Lengan	Intervensi / pengobatan
Placebo Comparator: Placebo Identical in taste and colour to the supplement juice, but with no anthocyanin content
Experimental: Cherry juice 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Experimental: Blueberry 30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,

Kriteria kelayakan

Usia yang Layak untuk Belajar	18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk Belajar	All
Menerima Relawan Sehat	Iya
Kriteria	Inclusion Criteria: - Healthy - 18 years of age and above Exclusion Criteria: - Pregnancy - Diabetes or any other metabolic conditions - Food allergies to cherries or blueberries

Hasil

Ukuran Hasil Utama

1. Change in blood pressure [20 days]

Systolic and diastolic blood pressure - measured using a digital blood pressure monitor

2. Change in % bodyfat [20 days]

Participants percentage composition of fat - measured using bio-electrical impedance

3. Change in waist to hip ratio [20 days]

Ratio of waist to hip circumference - measured using anthropocentric tape

4. Change in resting metabolic rate [20 days]

Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.

5. Change in resting utilization of fats [20 days]

% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

6. Change in resting utilization of carbohydrates [20 days]

% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.

7. Change in low intensity activity calories expended [20 days]

Estimated calorie usage (Kcal) during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

8. Change in low intensity activity utilization of fats [20 days]

% contribution of fats to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

9. Change in low intensity activity utilization of carbohydrates [20 days]

% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

10. Change in low-moderate intensity activity calories expended [20 days]

Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

11. Change in low-moderate intensity activity utilization of fats [20 days]

% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

12. Change in low-moderate intensity activity utilization of carbohydrates [20 days]

% contribution of carbohydrates to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.

13. Change in blood glucose [20 days]

Capillary blood glucose - mmol/L

14. Change in blood triglycerides [20 days]

Capillary blood triglycerides - mg/dl

15. Change in blood cholesterol [20 days]

Capillary blood cholesterol - mg/dl

16. Change in Coop-Wonka chart [20 days]

Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.

17. Change in Beck Depression Inventory [20 days]

Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.

18. Change in State Trait Anxiety Inventory [20 days]

Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.

19. Change in Insomnia Severity Index [20 days]

Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.

20. Change in Pittsburgh Sleep Quality Index [20 days]

Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.

21. Change in Epworth Sleepiness Scale [20 days]

Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.

Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Kata kunci

diabetes melitus tipe 2

diabetes mellitus

anthocyanin

prunus

kersen

antioksidan