Gut Hormone Response After Paleolithic-type Meals

NCT ID: NCT01999504

Last Updated: 2014-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Insulin Resistance; Satiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

PAL-2

Intervention Type: OTHER

meal

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).

Group Type: EXPERIMENTAL

TFH-1

Intervention Type: OTHER

Meal

Reference

Meal based on WHO dietary guidelines for protein, fat and carbohydrate.

Group Type: PLACEBO_COMPARATOR

Reference

Intervention Type: OTHER

Meal

Interventions

PAL-2

meal

Intervention Type: OTHER

TFH-1

Meal

Intervention Type: OTHER

Reference

Meal

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Leatherhead Food Research

INDUSTRY

Sponsor Role: collaborator

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Diaz-Toledo Trenado

Role: PRINCIPAL_INVESTIGATOR

Leatherhead Food Research

Locations

Leatherhead Food Research

Leatherhead, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

FDS-BNH-1268

Identifier Type: -

Identifier Source: org_study_id