An interventional study of PAL-2 and TFH-1 in Insulin Resistance and Satiety, sponsored by Unilever R&D. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-17.
Sponsored by Unilever R&D · Not applicable, Interventional, and Prevention
The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along the lines of the world Health Organisation dietary recommendations
In the current study the effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times (e.g. no cereals, no dairy).
Other: PAL-2
Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times, (e.g. no cereals, no dairy).
Other: TFH-1
Meal based on WHO dietary guidelines for protein, fat and carbohydrate.
Other: Reference
meal
Meal
Meal
Glucagon-like peptide-1
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
Time frame: 0-3 hours
Glucose-dependent Insulinotropic Peptide
Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma
Time frame: 0-3 hours
Fullness
Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time
Time frame: 0-4 hours
Glucose
Area under the Concentration versus time curve of Glucose in blood
Time frame: 0-3 hours
Insulin
Area under the Concentration versus time curve of insulin in blood plasma
Time frame: 0-3 hours
Glucagon
Area under the Concentration versus time curve of Glucagon in blood plasma
Time frame: 0-3 hours
Peptide YY
Area under the Concentration versus time curve of Peptide YY in blood plasma
Time frame: 0-3 hours
Hunger
Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time
Time frame: 0-4 hours
Desire to eat
Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time
Time frame: 0-4 hours
Insulin/glucose ratio
Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake
Time frame: 30 minutes
Ad libitum meal
Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake
Time frame: 4 hours
Time to return to baseline of satiety score for fullness, hunger and desire to eat
Time to return to baseline for the scores on a Visual Analogue Scales for fullness, hunger and desire to eat
Time frame: up to 4 hours
Peptide hormones
Area under the Concentration versus time curve for total amylin, ghrelin, pancreatic polypeptide, C-peptide, leptin, interleukin-6, monocyte chemotactic protein-1 and tumour necrosis factor-alpha in blood plasma
Time frame: 0-3 hours
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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