Gut Hormone Response After Paleolithic-type Meals
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Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
1 other identifier
interventional
24
1 country
1
Brief Summary
The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along the lines of the world Health Organisation dietary recommendations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 17, 2014
October 1, 2014
2 months
October 29, 2013
October 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucagon-like peptide-1
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
0-3 hours
Secondary Outcomes (8)
Glucose-dependent Insulinotropic Peptide
0-3 hours
Fullness
0-4 hours
Glucose
0-3 hours
Insulin
0-3 hours
Glucagon
0-3 hours
- +3 more secondary outcomes
Other Outcomes (4)
Insulin/glucose ratio
30 minutes
Ad libitum meal
4 hours
Time to return to baseline of satiety score for fullness, hunger and desire to eat
up to 4 hours
- +1 more other outcomes
Study Arms (3)
PAL-2
EXPERIMENTALBased on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times (e.g. no cereals, no dairy).
TFH-1
EXPERIMENTALBased on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times, (e.g. no cereals, no dairy).
Reference
PLACEBO COMPARATORMeal based on WHO dietary guidelines for protein, fat and carbohydrate.
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) 18-27 inclusive
- Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)
- Having general practitioner
- Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian
- Reported intense sporting activities less than 10h/w
- Reported alcohol consumption less than 21units/w
- non-smoking
- A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick
You may not qualify if:
- Use of medication which interferes with the study measurements (as judged by the study physician)
- Being an employee of Unilever or Leatherhead Food Research
- Scoff questionaire score ≥ 2
- Eating habit questionnaire ≥ 14
- Smoking
- Dislike, allergy or intolerance t the test meals or the ad libitum meal
- Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study
- Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unilever R&Dlead
- Leatherhead Food Researchcollaborator
Study Sites (1)
Leatherhead Food Research
Leatherhead, Surrey, KT22 7RY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Diaz-Toledo Trenado
Leatherhead Food Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
December 3, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2013
Study Completion
October 1, 2014
Last Updated
October 17, 2014
Record last verified: 2014-10