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Completed

NCT Number: NCT01418573

Glycemic Response After Palaeolithic-type Meals

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.

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Key information

Conditions

Glycemic Index of a Meal Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leatherhead Food Research

Leatherhead, Surrey, KT22 7RY, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palaeolithic meal 1

Other

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

Palaeolithic meal 2

Other

Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times

Reference meal

Other

Based on WHO dietary guidelines for protein, fat and carbohydrate.

Primary outcomes

  1. Blood glucose

    Time frame: 0-2 hours

    positive incremental area under the concentration versus time

  2. Plasma insulin

    Time frame: 0-2 hours

    net incremental area under the curve

  3. Peak blood glucose

    Time frame: 0-2 hours

    maximal blood glucose value

Secondary outcomes

  1. Satiety scores

    Time frame: 0-2 hours

    area under the curve

  2. Gut hormone panel

    Time frame: 0-3 hours

    Average concentration over time

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Leatherhead Food Research

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2011
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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