Gut Hormone Response After Paleolithic-type Meals (FooA2)

Unilever

Status: Completed

Conditions: Satiety; Insulin Resistance

Treatments: Other: PAL-2; Other: Reference; Other: TFH-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01999504

FDS-BNH-1268

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

PAL-2

Experimental group

Description:

Based 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).

Treatment:

Other: PAL-2

TFH-1

Experimental group

Description:

Based 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).

Treatment:

Other: TFH-1

Reference

Placebo Comparator group

Description:

Meal based on WHO dietary guidelines for protein, fat and carbohydrate.

Treatment:

Other: Reference