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Completed

NCT Number: NCT01999504

Gut Hormone Response After Paleolithic-type Meals

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

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leatherhead Food Research

Leatherhead, Surrey, KT22 7RY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAL-2

Other

meal

TFH-1

Other

Meal

reference

Other

Meal

Primary outcomes

  1. Glucagon-like peptide-1

    Time frame: 0-3 hours

    Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma

Secondary outcomes

  1. Glucose-dependent Insulinotropic Peptide

    Time frame: 0-3 hours

    Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma

  2. Fullness

    Time frame: 0-4 hours

    Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time

  3. Glucose

    Time frame: 0-3 hours

    Area under the Concentration versus time curve of Glucose in blood

  4. Insulin

    Time frame: 0-3 hours

    Area under the Concentration versus time curve of insulin in blood plasma

  5. Glucagon

    Time frame: 0-3 hours

    Area under the Concentration versus time curve of Glucagon in blood plasma

  6. Peptide YY

    Time frame: 0-3 hours

    Area under the Concentration versus time curve of Peptide YY in blood plasma

  7. Hunger

    Time frame: 0-4 hours

    Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time

  8. Desire to eat

    Time frame: 0-4 hours

    Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time

Other outcomes

  1. Insulin/glucose ratio

    Time frame: 30 minutes

    Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake

  2. Ad libitum meal

    Time frame: 4 hours

    Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake

  3. Time to return to baseline of satiety score for fullness, hunger and desire to eat

    Time frame: up to 4 hours

    Time to return to baseline for the scores on a Visual Analogue Scales for fullness, hunger and desire to eat

  4. Peptide hormones

    Time frame: 0-3 hours

    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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Leatherhead Food Research

Registry information

Official study title

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

Acronym: FooA2

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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