- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
Berkeley, California, Stati Uniti, 94705
- Cholesterol Research Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Standard Reference Diet
|
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
|
Sperimentale: Almond Supplemented Diet
|
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
|
Comparatore attivo: Low Carbohydrate Reference Diet
|
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Total and LDL cholesterol
Lasso di tempo: 3 weeks, 8 weeks, 13 weeks
|
Change in total and LDL cholesterol between each of the 3 test diets
|
3 weeks, 8 weeks, 13 weeks
|
Change in small and medium LDL particles
Lasso di tempo: 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
Lasso di tempo: 3 weeks, 8 week, 13 weeks
|
Change in apolipoprotein B between each of the 3 test diets
|
3 weeks, 8 week, 13 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in total/HDL-cholesterol ratio
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MM2222
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Standard reference diet
-
Mondelēz International, Inc.KGK Science Inc.Completato
-
Hospital de Clinicas de Porto AlegreTerminatoPressione sanguignaBrasile
-
University of GlasgowCompletatoMorbo di Crohn | Modifica dieteticaRegno Unito
-
University of HawaiiNational Cancer Institute (NCI); National Institutes of Health (NIH); University...Reclutamento
-
Wolfson Medical CenterTerminatoColite ulcerosaIsraele, Francia, Italia
-
American University of Beirut Medical CenterReclutamentoObesità | Perdita di pesoLibano
-
Quadram Institute BioscienceUniversity of East Anglia; The Coca-Cola CompanyCompletato
-
University of CalgaryStewart Diabetes Education FundCompletatoObesità | Diabete mellito di tipo 2Canada
-
Vegenat, S.A.SconosciutoMorbo di Parkinson | Il morbo di Alzheimer | Demenza senileSpagna
-
International Centre for Diarrhoeal Disease Research...ReclutamentoBambini malnutritiBangladesh