Back to resultsGut Hormone Response After Paleolithic-type Meals (FooA2)
Primary Purpose
Insulin Resistance, Satiety
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PAL-2
TFH-1
Reference
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) 18-27 inclusive
- Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)
- Having general practitioner
- Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian
- Reported intense sporting activities less than 10h/w
- Reported alcohol consumption less than 21units/w
- non-smoking
- A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick
Exclusion Criteria:
- Use of medication which interferes with the study measurements (as judged by the study physician)
- Being an employee of Unilever or Leatherhead Food Research
- Scoff questionaire score ≥ 2
- Eating habit questionnaire ≥ 14
- Smoking
- Dislike, allergy or intolerance t the test meals or the ad libitum meal
- Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study
- Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM
Sites / Locations
- Leatherhead Food Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PAL-2
TFH-1
Reference
Arm Description
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).
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).
Meal based on WHO dietary guidelines for protein, fat and carbohydrate.
Outcomes
Primary Outcome Measures
Glucagon-like peptide-1
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
Secondary Outcome Measures
Glucose-dependent Insulinotropic Peptide
Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma
Fullness
Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time
Glucose
Area under the Concentration versus time curve of Glucose in blood
Insulin
Area under the Concentration versus time curve of insulin in blood plasma
Glucagon
Area under the Concentration versus time curve of Glucagon in blood plasma
Peptide YY
Area under the Concentration versus time curve of Peptide YY in blood plasma
Hunger
Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time
Desire to eat
Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time
Full Information
NCT ID
NCT01999504
First Posted
October 29, 2013
Last Updated
October 16, 2014
Sponsor
Unilever R&D
Collaborators
Leatherhead Food Research
1. Study Identification
Unique Protocol Identification Number
NCT01999504
Brief Title
Gut Hormone Response After Paleolithic-type Meals
Acronym
FooA2
Official Title
Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
Leatherhead Food Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Satiety
Keywords
Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAL-2
Arm Type
Experimental
Arm Description
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).
Arm Title
TFH-1
Arm Type
Experimental
Arm Description
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).
Arm Title
Reference
Arm Type
Placebo Comparator
Arm Description
Meal based on WHO dietary guidelines for protein, fat and carbohydrate.
Intervention Type
Other
Intervention Name(s)
PAL-2
Intervention Description
meal
Intervention Type
Other
Intervention Name(s)
TFH-1
Intervention Description
Meal
Intervention Type
Other
Intervention Name(s)
Reference
Intervention Description
Meal
Primary Outcome Measure Information:
Title
Glucagon-like peptide-1
Description
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
Time Frame
0-3 hours
Secondary Outcome Measure Information:
Title
Glucose-dependent Insulinotropic Peptide
Description
Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma
Time Frame
0-3 hours
Title
Fullness
Description
Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time
Time Frame
0-4 hours
Title
Glucose
Description
Area under the Concentration versus time curve of Glucose in blood
Time Frame
0-3 hours
Title
Insulin
Description
Area under the Concentration versus time curve of insulin in blood plasma
Time Frame
0-3 hours
Title
Glucagon
Description
Area under the Concentration versus time curve of Glucagon in blood plasma
Time Frame
0-3 hours
Title
Peptide YY
Description
Area under the Concentration versus time curve of Peptide YY in blood plasma
Time Frame
0-3 hours
Title
Hunger
Description
Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time
Time Frame
0-4 hours
Title
Desire to eat
Description
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
Other Pre-specified Outcome Measures:
Title
Insulin/glucose ratio
Description
Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake
Time Frame
30 minutes
Title
Ad libitum meal
Description
Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake
Time Frame
4 hours
Title
Time to return to baseline of satiety score for fullness, hunger and desire to eat
Description
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
Title
Peptide hormones
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body Mass Index (BMI) 18-27 inclusive
Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)
Having general practitioner
Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian
Reported intense sporting activities less than 10h/w
Reported alcohol consumption less than 21units/w
non-smoking
A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick
Exclusion Criteria:
Use of medication which interferes with the study measurements (as judged by the study physician)
Being an employee of Unilever or Leatherhead Food Research
Scoff questionaire score ≥ 2
Eating habit questionnaire ≥ 14
Smoking
Dislike, allergy or intolerance t the test meals or the ad libitum meal
Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study
Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Diaz-Toledo Trenado
Organizational Affiliation
Leatherhead Food Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leatherhead Food Research
City
Leatherhead
State/Province
Surrey
ZIP/Postal Code
KT22 7RY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Gut Hormone Response After Paleolithic-type Meals
We'll reach out to this number within 24 hrs