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The Healthy Cantonese Diet on Cardiometabolic Syndrome

19. August 2019 aktualisiert von: Huilian Zhu, Sun Yat-sen University

Effect of the Healthy Cantonese Diet on Cardiometabolic Syndrome in Chinese Adults

The DASH diet (Dietary Approaches to Stop Hypertension) have been proven to lower risk of cardiovascular diseases. But the DASH diet is inconsistent with Chinese dietary pattern. In this study, based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016. The randomized control trial is designed to investigate whether the healthy Cantonese diet has benefit to blood pressure, blood lipid, blood glucose and other cardiometabolic biomarkers among adults with cardiometabolic syndrome in Guangdong, China.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Age 25-75 years old, male or female;
  2. have lived in this community for the past six months, and have no plans to move out or go out in the next three months;
  3. the systolic blood pressure is within 130-159mmHg regardless of medication.
  4. maintaining the current medication (mainly drugs for hypertension, diabetes or hyperlipidemia) throughout the research period, with the category and dose unchanged;
  5. the number of test meal consumed is no less than 18;
  6. community feeding mode: eat a meal at least once a day at the research center (preferably lunch or dinner); or home delivery mode: upload meal pictures for three meals every day, and eat a meal and have physical examination at the research center at least once a week;
  7. sign the informed consent form.

Exclusion Criteria:

  1. fasting blood glucose ≥10.0mmol/L;
  2. total cholesterol ≥7.2mmol/L;
  3. injected inulin within a month;
  4. unwilling or unable to change the original dietary pattern, or have special dietary needs (such as vegetarians);
  5. alcoholism;
  6. BMI ≥30kg/m^2, or losing weight currently;
  7. have acute cardiovascular and cerebrovascular events occurred in the past six months;
  8. have a history of chronic kidney disease, intestinal irritation or asthma;
  9. women who have been/are preparing for pregnancy or lactation;
  10. in combination with other serious diseases such as cancer, chronic heart failure, severe depression or other mental disorders, long-term bedridden or unable to move freely;
  11. have a history of common food allergies (eggs, seafood, peanuts, etc.);
  12. have undergone gastrointestinal surgery;
  13. currently suffering from acute phase of diseases such as respiratory infections, fever, severe diarrhea;
  14. have deaf-mutism, dementia, unable to communicate properly.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: the healthy Cantonese diet
Based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016. In this diet, the main nutrients, dietary fiber, sodium, calcium, magnesium and potassium are set to achieve the healthy goal. Compared with the typical Cantonese diet, the healthy Cantonese diet is increased in fruit, vegetables, low-fat dairy products, whole grains, nuts and seeds, and reduced in salt, oil and sweets.
Sonstiges: the healthy Cantonese diet
After a 1-week run-in period, the intervention group will eat the healthy Cantonese diet for 4 consecutive weeks. Free meals will be provided 3 times a day (breakfast, lunch, dinner). The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake. All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.
Placebo-Komparator: the typical Cantonese diet
The typical Cantonese diet is a diet of what many Cantonese eat. In this diet, the main nutrients, dietary fiber, sodium, calcium, magnesium and potassium are set at the average dietary intake levels in Guangdong.
Sonstiges: the typical Cantonese diet
After a 1-week run-in period, the control group will still eat the typical Cantonese diet for 4 consecutive weeks. Free meals will be provided 3 times a day (breakfast, lunch, dinner). The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake. All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Metabolic syndrome score
Zeitfenster: before and after 4-week intervention
Changes of metabolic syndrome score in healthy Cantonese diet compared with changes of typical Cantonese diet. Metabolic syndrome score will be derived by standardizing and then summing the following continuously distributed indices of adiposity (waist circumference) to create a z score: hypertension (the average of systolic blood pressure and diastolic blood pressure); hyperglycaemia (fasting plasma glucose); insulin resistance (fasting insulin); fasting HDL-cholesterol × -1; and fasting triacylglycerol z score.
before and after 4-week intervention
Systolic blood pressure and diastolic blood pressure
Zeitfenster: before and after 4-week intervention
Changes of systolic blood pressure and diastolic blood pressure in healthy Cantonese diet compared with changes of typical Cantonese diet. Blood pressure will be measured by trained investigator at baseline, week 1, week 2, week 3 and week 4, and systolic blood pressure and diastolic blood pressure will be recorded.
before and after 4-week intervention
Blood lipid profile
Zeitfenster: before and after 4-week intervention
Changes of blood lipid profile in healthy Cantonese diet compared with changes of typical Cantonese diet. Blood lipid profile (total cholesterol, TC; triglyceride, TG; LDL cholesterol, LDLc; HDL cholesterol, HDLc) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
before and after 4-week intervention
Glucose metabolism
Zeitfenster: before and after 4-week intervention
Changes of glucose metabolism in healthy Cantonese diet compared with changes of typical Cantonese diet. Glucose metabolism (fasting plasma glucose and fasting insulin) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4 and insulin resistance index (HOMA-IR) will be calculated by [fasting insulin (mU/L) × fasting plasma glucose (mmol/L) ]/22.5.
before and after 4-week intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood biochemical marker
Zeitfenster: before and after 4-week intervention
Changes of blood biochemical marker in healthy Cantonese diet compared with changes of typical Cantonese diet. Blood biochemical marker (calcium, potassium, sodium, magnesium and phosphorus in mmol/L; uric acid in μmol/L) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
before and after 4-week intervention
Urinary sodium and potassium
Zeitfenster: before and after 4-week intervention
Changes of urinary sodium and potassium in healthy Cantonese diet compared with changes of typical Cantonese diet. Urinary sodium and potassium will be tested by a validated biomedical analyses laboratory using morning urine at baseline and week 4.
before and after 4-week intervention
Intestinal microbiota composition
Zeitfenster: before and after 4-week intervention
Changes of intestinal microbiota composition in healthy Cantonese diet compared with changes of typical Cantonese diet.
before and after 4-week intervention
Gut microbial gene richness
Zeitfenster: before and after 4-week intervention
Changes of gut microbial gene richness in healthy Cantonese diet compared with changes of typical Cantonese diet.
before and after 4-week intervention
Inflammatory biomarkers
Zeitfenster: before and after 4-week intervention
Changes of inflammatory biomarkers in healthy Cantonese diet compared with changes of typical Cantonese diet. Inflammatory biomarkers (CRP in mg/L; Tumor TNF-α and IL-6 in ng/L) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
before and after 4-week intervention
Cardiopulmonary function
Zeitfenster: before and after 4-week intervention
Changes of cardiopulmonary function in healthy Cantonese diet compared with changes of typical Cantonese diet. Cardiopulmonary function will be measured by cardiopulmonary exercise testing using CORTEX MetaLyzer 3B at baseline and week 4.
before and after 4-week intervention
Endothelial function
Zeitfenster: before and after 4-week intervention
Changes of endothelial function in healthy Cantonese diet compared with changes of typical Cantonese diet. Flow-mediated dilatation (FMD) will be assessed to evaluate endothelial function by using UNEX EF38G at baseline and week 4.
before and after 4-week intervention
Body composition
Zeitfenster: before and after 4-week intervention
Changes of body composition in healthy Cantonese diet compared with changes of typical Cantonese diet. Body composition will be tested by using dual energy X-ray absorptiometry at baseline and week 4.
before and after 4-week intervention
Body mass index (BMI)
Zeitfenster: before and after 4-week intervention
Height in meters and weight in kilograms will be combined to report body mass index (BMI) in kg/m^2.
before and after 4-week intervention
Ratio of waist to hip circumference (WHR)
Zeitfenster: before and after 4-week intervention
Waist circumference in centimeters and hip circumference in centimeters will be combined to report ratio of waist to hip circumference (WHR).
before and after 4-week intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sun Yat-sen University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. September 2019

Primärer Abschluss (Voraussichtlich)

31. Dezember 2021

Studienabschluss (Voraussichtlich)

31. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

12. August 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. August 2019

Zuerst gepostet (Tatsächlich)

21. August 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. August 2019

Zuletzt verifiziert

1. August 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CC-2019-03

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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