Gut Hormone Response After Paleolithic-type Meals (FooA2)

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

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

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Satiety
• Intervention / Treatment: Other: PAL-2; Other: TFH-1; Other: Reference

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Leatherhead, Surrey, United Kingdom, KT22 7RY
      • Leatherhead Food Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin/glucose ratio	Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake	30 minutes
Ad libitum meal	Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake	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	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	0-3 hours

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Leatherhead Food Research
• Investigators: Principal Investigator: Carmen Diaz-Toledo Trenado, Leatherhead Food Research

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Meal; Satiety; Glucagon; Glucagon-like peptide-1; Glucose-dependent Insulinotropic Peptide; Peptide YY; palaeolithic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: FDS-BNH-1268