Glycemic Response After Palaeolithic-type Meals

August 12, 2013 updated by: Unilever R&D

Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines

The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO dietary recommendations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effects of this set of meals will be assessed with respect to blood

  • blood glucose
  • plasma insulin
  • satiety scores
  • plasma gut hormones It is hypothesised that lower post prandial blood glucose concentration, a lower insulin response and increased satiety will be seen after the Palaeolithic meals compared with a reference meal

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • ≥ 18 and ≤ 60 years old
  • Body mass index (BMI) ≥ 18 and ≤ 27.0 kg/m2
  • Apparently healthy
  • Not smoking
  • A fasting blood glucose value within the normal reference value

Exclusion Criteria:

- No prescribed medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Palaeolithic-type meal 1
Other: Palaeolithic meal 1
Based on estimated ratios for protein, fat and carbohydrates that are typical of Hunter-Gatherers and does not contain ingredients that were not available in pre-neolithic times
EXPERIMENTAL: Palaeolithic-type meal 2
Other: Palaeolithic meal 2
Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times
PLACEBO_COMPARATOR: The reference meal
Other: Reference meal
Based on WHO dietary guidelines for protein, fat and carbohydrate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: 0-2 hours
positive incremental area under the concentration versus time
0-2 hours
Plasma insulin
Time Frame: 0-2 hours
net incremental area under the curve
0-2 hours
Peak blood glucose
Time Frame: 0-2 hours
maximal blood glucose value
0-2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satiety scores
Time Frame: 0-2 hours
area under the curve
0-2 hours
Gut hormone panel
Time Frame: 0-3 hours
Average concentration over time
0-3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Collaborators

Leatherhead Food Research

Investigators

  • Principal Investigator: Sonia Pombo, Leatherhead Food Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (ESTIMATE)

August 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDS-BNH-0100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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