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Gut Hormone Response After Paleolithic-type Meals (FooA2)

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ClinicalTrials.gov Identifier: NCT01999504
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
Leatherhead Food Research
Information provided by (Responsible Party):
Unilever R&D

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

Condition or disease Intervention/treatment Phase
Insulin Resistance Satiety Other: PAL-2 Other: TFH-1 Other: Reference Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: PAL-2
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).
Other: PAL-2
meal

Experimental: TFH-1
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).
Other: TFH-1
Meal

Placebo Comparator: Reference
Meal based on WHO dietary guidelines for protein, fat and carbohydrate.
Other: Reference
Meal




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999504


Locations
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United Kingdom
Leatherhead Food Research
Leatherhead, Surrey, United Kingdom, KT22 7RY
Sponsors and Collaborators
Unilever R&D
Leatherhead Food Research
Investigators
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Principal Investigator: Carmen Diaz-Toledo Trenado Leatherhead Food Research

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01999504     History of Changes
Other Study ID Numbers: FDS-BNH-1268
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by Unilever R&D:
Glucagon-like peptide-1
Glucose-dependent Insulinotropic Peptide
Peptide YY
Glucagon
Satiety
Meal
palaeolithic

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Glucagon
Gastric Inhibitory Polypeptide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Incretins