Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595082
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPERLUPINO
Brief Summary:
The aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid glucose inflammatory oxidative stress gut microbiota profile and epigenetic markers in healthy volunteers by means of a 4-week 2-arm parallel randomized controlled trial
Detailed Description:
Epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health Among the dietary patterns it has been showed that the adherence to a plant-based diet ie Mediterranean diet may have a pivotal role in promoting a health longevity and counteracting cardiovascular neurological and cancer-related diseases In fact the abundant consumption of fruit vegetables cereals and pulses leads to a high intake of vegetable proteins unsaturated fatty acids minerals vitamins fibre and bioactive compounds which may have anti-inflammatory antioxidant anti-atherosclerotic hypocholesterolemic and antimicrobial activities In particular there is a growing interest for valorization of pulses among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal Lupins are traditional legumes of the Mediterranean basin and they represent a good source of bioactive peptides soluble fibre and minerals Different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure reduction of blood glucose cholesterol triglycerides and uric acid
Nevertheless there is still a lack of information regarding the effects of the consumption of whole lupins and in particular in one of the most sold forms as in brine
In this parallel randomized controlled trial 60 healthy volunteers were randomly allocated for a 4-week consumption of
Active comparator arm 30 grams per week of lupins in brine
Experimental arm 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat processed meat andor cheese
At baseline and after 4 weeks of dietary intervention subjects were visited in medical facility and asked to provide blood urine saliva feces for the evaluation of
Anthropometric and blood pressure parameters
Blood lipid and carbohydrate profile
Blood transaminase parameters
Blood and urine inflammation markers
Leucocyte and saliva DNA genetic and epigenetic markers
Fecal profile of gut microbiota In addition volunteers filled in different questionnaires regarding their dietary habits the physical activity and the gut healthiness
Nevertheless there is still a lack of information regarding the effects of the consumption of whole lupins and in particular in one of the most sold forms as in brine
In this parallel randomized controlled trial 60 healthy volunteers were randomly allocated for a 4-week consumption of
Active comparator arm 30 grams per week of lupins in brine
Experimental arm 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat processed meat andor cheese
At baseline and after 4 weeks of dietary intervention subjects were visited in medical facility and asked to provide blood urine saliva feces for the evaluation of
Anthropometric and blood pressure parameters
Blood lipid and carbohydrate profile
Blood transaminase parameters
Blood and urine inflammation markers
Leucocyte and saliva DNA genetic and epigenetic markers
Fecal profile of gut microbiota In addition volunteers filled in different questionnaires regarding their dietary habits the physical activity and the gut healthiness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None