Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538831
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
Status:
RECRUITING
Status Verified Date:
2024-10
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:
NOVA
Brief Summary:
The goal of this clinical trial is to examine in a 2x2 factorial RCT what features of ultra-processed foods UPFs contribute to cardiometabolic risk in men and women The projects hypotheses are
1 that the nutrient composition of UPFs high SFA free sugar and sodium per se has deleterious impacts on cardiometabolic risk factors
2 that the industrial techniques and processes of UPFs per se do not
Participants will be randomly assigned to one of 4 groups consistent with the 2x2 factorial design of the study 1- the nutrient composition of foods low vs high in SFA free sugar and sodium and 2- the degree of industrial techniques and food processing little to no vsimportant amounts of UPFs All foods will be provided to participants under isocaloric conditions during the 6-week dietary intervention Participants will have to consume one of the 4 experimental diets for 6 weeks
1 that the nutrient composition of UPFs high SFA free sugar and sodium per se has deleterious impacts on cardiometabolic risk factors
2 that the industrial techniques and processes of UPFs per se do not
Participants will be randomly assigned to one of 4 groups consistent with the 2x2 factorial design of the study 1- the nutrient composition of foods low vs high in SFA free sugar and sodium and 2- the degree of industrial techniques and food processing little to no vsimportant amounts of UPFs All foods will be provided to participants under isocaloric conditions during the 6-week dietary intervention Participants will have to consume one of the 4 experimental diets for 6 weeks
Detailed Description:
This study is a parallel group 2x2 factorial randomized controlled trial in which diet is fully controlled A total of 120 men and women covering a broad range of adiposity and cardiometabolic risk factors will be randomly assigned to one of four 6-week experimental diets
1 A diet low in saturated fatty acids SFAs free sugar and sodium with low ultra-processed foods UPFs
2 A diet rich in SFAs free sugar and sodium with low UPFs
3 A diet low in SFAs free sugar and sodium with high levels of UPFs
4 A diet rich in SFAs free sugar and sodium with high levels of UPFs
All foods in this full-feeding trial will be managed or prepared by food technicians at the Clinical Investigation Unit of our research center A cyclic seven-day menu plan will be developed with similar foods across the four diets Classifications of the degree of food processing will be made using NOVA classification NOVA identifies four categories of foods based on the degree of food processing 1- Unprocessed or minimally processed foods 2- Processed Culinary Ingredients 3- Processed Food and 4- Ultra-processed foods UPFs The two diets high in UPFs will predominantly feature commercially-bought foods classified as NOVA-4 while the two diets low in UPFs diets will predominantly include foods prepared in our metabolic kitchen NOVA 1 to 3 Diets will be provided under isocaloric conditions to maintain body weight constant The breakfast meal will represent approximately 30 of the daily energy intake in each diet whereas the lunch and dinner meals each will provide about 35 of daily energy intake Participants will have to come to the research center 3 to 5 times a week during the 6-week intervention to collect their meals and be weighed Primary and secondary outcomes will be measured at the beginning and at the end of the 6-wk diet intervention
The specifics objectives of this 2x2 factorial RCT are
Obj 1 To assess the impact of the nutrient composition of UPFs on cardiometabolic risk independent of variations in industrial techniques and processes factor 1
Obj 2 To assess the impact of industrial techniques and processes of UPFs on cardiometabolic risk independent of variations in nutrient composition factor 2
1 A diet low in saturated fatty acids SFAs free sugar and sodium with low ultra-processed foods UPFs
2 A diet rich in SFAs free sugar and sodium with low UPFs
3 A diet low in SFAs free sugar and sodium with high levels of UPFs
4 A diet rich in SFAs free sugar and sodium with high levels of UPFs
All foods in this full-feeding trial will be managed or prepared by food technicians at the Clinical Investigation Unit of our research center A cyclic seven-day menu plan will be developed with similar foods across the four diets Classifications of the degree of food processing will be made using NOVA classification NOVA identifies four categories of foods based on the degree of food processing 1- Unprocessed or minimally processed foods 2- Processed Culinary Ingredients 3- Processed Food and 4- Ultra-processed foods UPFs The two diets high in UPFs will predominantly feature commercially-bought foods classified as NOVA-4 while the two diets low in UPFs diets will predominantly include foods prepared in our metabolic kitchen NOVA 1 to 3 Diets will be provided under isocaloric conditions to maintain body weight constant The breakfast meal will represent approximately 30 of the daily energy intake in each diet whereas the lunch and dinner meals each will provide about 35 of daily energy intake Participants will have to come to the research center 3 to 5 times a week during the 6-week intervention to collect their meals and be weighed Primary and secondary outcomes will be measured at the beginning and at the end of the 6-wk diet intervention
The specifics objectives of this 2x2 factorial RCT are
Obj 1 To assess the impact of the nutrient composition of UPFs on cardiometabolic risk independent of variations in industrial techniques and processes factor 1
Obj 2 To assess the impact of industrial techniques and processes of UPFs on cardiometabolic risk independent of variations in nutrient composition factor 2
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