Gut Hormone Response After Paleolithic-type Meals

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines

Conditions
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Insulin Resistance, Satiety

Intervention / Treatment
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* Other: PAL-2
* Other: TFH-1
* Other: Reference


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAL-2<br>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<br>* meal<br>|
| Experimental: TFH-1<br>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<br>* Meal<br>|
| Placebo Comparator: Reference<br>Meal based on WHO dietary guidelines for protein, fat and carbohydrate. | Other: Reference<br>* Meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon-like peptide-1 | Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma | 0-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose-dependent Insulinotropic Peptide | Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma | 0-3 hours | 
| Fullness | Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time | 0-4 hours | 
| Glucose | Area under the Concentration versus time curve of Glucose in blood | 0-3 hours | 
| Insulin | Area under the Concentration versus time curve of insulin in blood plasma | 0-3 hours | 
| Glucagon | Area under the Concentration versus time curve of Glucagon in blood plasma | 0-3 hours | 
| Peptide YY | Area under the Concentration versus time curve of Peptide YY in blood plasma | 0-3 hours | 
| Hunger | Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time | 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 | 0-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic