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Glycemic Response After Palaeolithic-type Meals

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ClinicalTrials.gov Identifier: NCT01418573
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : August 13, 2013
Sponsor:
Collaborator:
Leatherhead Food Research
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
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 or disease Intervention/treatment Phase
Glycemic Index of a Meal Other: Palaeolithic meal 1 Other: Palaeolithic meal 2 Other: Reference meal Not Applicable

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  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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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


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