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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: August 12, 2013
Last verified: February 2012
  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:


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
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, see Learn About Clinical Studies.

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: August 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 20, 2014