- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01792648
Effects of Almond Intake on Atherogenic Lipoprotein Particles
Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.
Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.
The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.
This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).
We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
California
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Berkeley, California, Vereinigte Staaten, 94705
- Cholesterol Research Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 20 or older
- Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
- Fasting blood sugar (FBS) < 126 mg/dl
- Weight stable for > 3 months.
Exclusion Criteria:
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
- Body mass index (BMI) > 38 kg/m2
- User of nicotine products or recreational drugs
- Refusal to abstain from alcohol or dietary supplements during the study.
- Total- and LDL-C > 95th percentile for sex and age.
- Fasting triglycerides > 50mg/dl and > 500 mg/dl
- Abnormal thyroid stimulating hormone (TSH) levels.
- Pregnant or breast-feeding
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Standard Reference Diet
|
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
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Experimental: Almond Supplemented Diet
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50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
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Aktiver Komparator: Low Carbohydrate Reference Diet
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26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Total and LDL cholesterol
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in total and LDL cholesterol between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in small and medium LDL particles
Zeitfenster: 3 weeks, 8 weeks, and 13 weeks
|
Change in small and medium LDL particles between each of the 3 test diets
|
3 weeks, 8 weeks, and 13 weeks
|
Change in apolipoprotein B
Zeitfenster: 3 weeks, 8 week, 13 weeks
|
Change in apolipoprotein B between each of the 3 test diets
|
3 weeks, 8 week, 13 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in total/HDL-cholesterol ratio
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in total/HDL-cholesterol ratio between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in LDL peak particle diameter
Zeitfenster: 3 weeks, 8 week, 13 weeks
|
Change in LDL peak particle diameter between each of the 3 test diets
|
3 weeks, 8 week, 13 weeks
|
Change in plasma triglycerides
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in plasma triglycerides between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in HDL-cholesterol
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in HDL-cholesterol between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in large HDL particles
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in large HDL particles between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in apolipoprotein AI
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in apolipoprotein AI between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in HOMA-IR
Zeitfenster: 3 weeks, 8 weeks, 13 weeks
|
Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MM2222
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