Gut Hormone Response After Paleolithic-type Meals

Insulin Resistance Clinical Trial

— FooA2  

Official title:

Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999504
• Other study ID #: FDS-BNH-1268
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: October 16, 2014
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Independent Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Satiety

Intervention

Other:
• PAL-2
meal
• TFH-1
Meal
• Reference
Meal

Locations

Country	Name	City	State
United Kingdom	Leatherhead Food Research	Leatherhead	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Leatherhead Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin/glucose ratio	Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake	30 minutes	No
Other	Ad libitum meal	Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake	4 hours	No
Other	Time to return to baseline of satiety score for fullness, hunger and desire to eat	Time to return to baseline for the scores on a Visual Analogue Scales for fullness, hunger and desire to eat	up to 4 hours	No
Other	Peptide hormones	Area under the Concentration versus time curve for total amylin, ghrelin, pancreatic polypeptide, C-peptide, leptin, interleukin-6, monocyte chemotactic protein-1 and tumour necrosis factor-alpha in blood plasma	0-3 hours	No
Primary	Glucagon-like peptide-1	Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma	0-3 hours	No
Secondary	Glucose-dependent Insulinotropic Peptide	Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma	0-3 hours	No
Secondary	Fullness	Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time	0-4 hours	No
Secondary	Glucose	Area under the Concentration versus time curve of Glucose in blood	0-3 hours	No
Secondary	Insulin	Area under the Concentration versus time curve of insulin in blood plasma	0-3 hours	No
Secondary	Glucagon	Area under the Concentration versus time curve of Glucagon in blood plasma	0-3 hours	No
Secondary	Peptide YY	Area under the Concentration versus time curve of Peptide YY in blood plasma	0-3 hours	No
Secondary	Hunger	Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time	0-4 hours	No
Secondary	Desire to eat	Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time	0-4 hours	No