The Metabolic Effect of Walnuts in Healthy Subjects
Nøgleord
Abstrakt
Beskrivelse
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.
Datoer
| Sidst bekræftet: | 07/31/2017 |
| Først indsendt: | 12/28/2014 |
| Anslået tilmelding indsendt: | 12/28/2014 |
| Først indsendt: | 12/30/2014 |
| Sidste opdatering indsendt: | 08/27/2017 |
| Sidste opdatering indsendt: | 08/28/2017 |
| Faktisk startdato for undersøgelsen: | 11/30/2014 |
| Anslået primær afslutningsdato: | 06/30/2016 |
| Anslået afslutningsdato for undersøgelsen: | 06/30/2017 |
Tilstand eller sygdom
Intervention / behandling
Other: walnuts
Fase
Armgrupper
| Arm | Intervention / behandling |
|---|---|
| Experimental: walnut-CH Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates | |
| Experimental: Walnut-SFA Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids | |
| Experimental: Walnut-LIB Western type diet including walnuts (43g/day); no specific recommendation | |
| No Intervention: Control Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind |
Kriterier for støtteberettigelse
| Alder berettiget til undersøgelse | 50 Years Til 50 Years |
| Køn, der er berettiget til undersøgelse | All |
| Accepterer sunde frivillige | Ja |
| Kriterier | Inclusion Criteria: - Postmenopausal healthy women and healthy men - Age >50 yrs - Written informed consent prior to study participation Exclusion Criteria: - Known allergy to nuts - Evidence of alcohol (women >70g/week, men >140g/week), tabacco or drug abuse - Obesity ≥35 kg/m2 - Diabetes mellitus - Hypertension >140/90 mmHg or history of hypertension - LDL-cholesterol >190 mg/dl, Triglycerides > 350 mg/dl - History of atherosclerotic disease - Liver disease of any etiology - Kidney disease of any etiology (GFR < 60 ml/min/1.73) - Uncontrolled thyroid disease or other endocrine diseases - Acute or chronic inflammatory diseases - Active malignancy - Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy - major surgical intervention within 3 months (or planned) |
Resultat
Primære resultatforanstaltninger
1. Non-HDL-cholesterol [8 weeks]
Sekundære resultatforanstaltninger
1. LDL-cholesterol [8 weeks]
2. total-cholesterol [8 weeks]
3. apoB [8 weeks]
4. triglycerides [8 weeks]
5. fasting glucose [8 weeks]
6. HOMA index [8 weeks]
7. caloric intake [8 weeks]
8. ratio CH:fat:protein [8 weeks]
9. ratio SFA:MUFA:PUFA [8 weeks]
