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Glycemic Response After Palaeolithic-type Meals

This study has been completed.
Sponsor:
Collaborator:
Leatherhead Food Research
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01418573
First received: August 16, 2011
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Glycemic Index of a Meal
 Other: Palaeolithic meal 1
Other: Palaeolithic meal 2
Other: Reference meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Blood glucose [ Time Frame: 0-2 hours ] [ Designated as safety issue: No ]
    positive incremental area under the concentration versus time

  • Plasma insulin [ Time Frame: 0-2 hours ] [ Designated as safety issue: No ]
    net incremental area under the curve

  • Peak blood glucose [ Time Frame: 0-2 hours ] [ Designated as safety issue: No ]
    maximal blood glucose value


Secondary Outcome Measures:
  • Satiety scores [ Time Frame: 0-2 hours ] [ Designated as safety issue: No ]
    area under the curve

  • Gut hormone panel [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]
    Average concentration over time


Enrollment: 24
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418573

Locations
United Kingdom
Leatherhead Food Research
Leatherhead, Surrey, United Kingdom, KT22 7RY
Sponsors and Collaborators
Unilever R&D
Leatherhead Food Research
Investigators
Principal Investigator: Sonia Pombo Leatherhead Food Research
  More Information

Publications:

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01418573     History of Changes
Other Study ID Numbers: FDS-BNH-0100
Study First Received: August 16, 2011
Last Updated: February 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Unilever R&D:
glucose, insulin, post prandial

ClinicalTrials.gov processed this record on May 22, 2013