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Glycemic Response After Palaeolithic-type Meals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418573
First Posted: August 17, 2011
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Leatherhead Food Research
Information provided by (Responsible Party):
Unilever R&D
  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
Intervention Model: Crossover Assignment
Masking: Single (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

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Blood glucose [ Time Frame: 0-2 hours ]
    positive incremental area under the concentration versus time

  • Plasma insulin [ Time Frame: 0-2 hours ]
    net incremental area under the curve

  • Peak blood glucose [ Time Frame: 0-2 hours ]
    maximal blood glucose value


Secondary Outcome Measures:
  • Satiety scores [ Time Frame: 0-2 hours ]
    area under the curve

  • Gut hormone panel [ Time Frame: 0-3 hours ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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