Clinical trial NCT01999504: Gut Hormone Response After Paleolithic-type Meals
Official title: Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Satiety
Keywords: Glucagon-like peptide-1
Glucose-dependent Insulinotropic Peptide
Peptide YY
Glucagon
Satiety
Meal
palaeolithic
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Leatherhead Food Research
First posted: 2013-12-03
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed description: In the current study the effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glucagon-like peptide-1
timeFrame: 0-3 hours
Secondary outcomes:
measure: Glucose-dependent Insulinotropic Peptide
timeFrame: 0-3 hours
measure: Fullness
timeFrame: 0-4 hours
measure: Glucose
timeFrame: 0-3 hours
measure: Insulin
timeFrame: 0-3 hours
measure: Glucagon
timeFrame: 0-3 hours
measure: Peptide YY
timeFrame: 0-3 hours
measure: Hunger
timeFrame: 0-4 hours
measure: Desire to eat
timeFrame: 0-4 hours
Other outcomes:
measure: Insulin/glucose ratio
timeFrame: 30 minutes
measure: Ad libitum meal
timeFrame: 4 hours
measure: Time to return to baseline of satiety score for fullness, hunger and desire to eat
timeFrame: up to 4 hours
measure: Peptide hormones
timeFrame: 0-3 hours
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research
state: Surrey
Study officials:
affiliation: Leatherhead Food Research
name: Carmen Diaz-Toledo Trenado
role: PRINCIPAL_INVESTIGATOR
References: