NCT01418573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 13, 2013

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

August 16, 2011

Last Update Submit

August 12, 2013

Conditions

Glycemic Index of a Meal

Keywords

glucose, insulin, post prandial

Outcome Measures

Primary Outcomes (3)

  • Blood glucose

    positive incremental area under the concentration versus time

    0-2 hours

  • Plasma insulin

    net incremental area under the curve

    0-2 hours

  • Peak blood glucose

    maximal blood glucose value

    0-2 hours

Secondary Outcomes (2)

  • Satiety scores

    0-2 hours

  • Gut hormone panel

    0-3 hours

Study Arms (3)

Palaeolithic-type meal 1

EXPERIMENTAL
Other: Palaeolithic meal 1

Palaeolithic-type meal 2

EXPERIMENTAL
Other: Palaeolithic meal 2

The reference meal

PLACEBO COMPARATOR
Other: Reference meal

Interventions

Palaeolithic meal 1OTHER

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-type meal 1
Palaeolithic meal 2OTHER

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

Palaeolithic-type meal 2
Reference mealOTHER

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

The reference meal

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- No prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leatherhead Food Research

Leatherhead, Surrey, KT22 7RY, United Kingdom

Location

Related Publications (3)

  • Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.

    PMID: 19209185BACKGROUND

  • Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.

    PMID: 19604407BACKGROUND

  • Bligh HF, Godsland IF, Frost G, Hunter KJ, Murray P, MacAulay K, Hyliands D, Talbot DC, Casey J, Mulder TP, Berry MJ. Plant-rich mixed meals based on Palaeolithic diet principles have a dramatic impact on incretin, peptide YY and satiety response, but show little effect on glucose and insulin homeostasis: an acute-effects randomised study. Br J Nutr. 2015 Feb 28;113(4):574-84. doi: 10.1017/S0007114514004012. Epub 2015 Feb 9.

    PMID: 25661189DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sonia Pombo

    Leatherhead Food Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

August 13, 2013

Record last verified: 2012-02

Locations

GB(1)