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Gut Hormone Response After Paleolithic-type Meals

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01999504
Acronym
FooA2
Enrollment
24
Registered
2013-12-03
Start date
2013-10-31
Completion date
2014-10-31
Last updated
2014-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Satiety

Keywords

Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic

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.

Interventions

OTHERPAL-2

meal

OTHERTFH-1

Meal

OTHERReference

Meal

Sponsors

Leatherhead Food Research
CollaboratorINDUSTRY
Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glucagon-like peptide-10-3 hoursArea under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma

Secondary

MeasureTime frameDescription
Glucose0-3 hoursArea under the Concentration versus time curve of Glucose in blood
Glucagon0-3 hoursArea under the Concentration versus time curve of Glucagon in blood plasma
Peptide YY0-3 hoursArea under the Concentration versus time curve of Peptide YY in blood plasma
Hunger0-4 hoursArea under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time
Desire to eat0-4 hoursArea under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time
Glucose-dependent Insulinotropic Peptide0-3 hoursArea under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma
Fullness0-4 hoursArea under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time
Insulin0-3 hoursArea under the Concentration versus time curve of insulin in blood plasma

Other

MeasureTime frameDescription
Time to return to baseline of satiety score for fullness, hunger and desire to eatup to 4 hoursTime to return to baseline for the scores on a Visual Analogue Scales for fullness, hunger and desire to eat
Peptide hormones0-3 hoursArea 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
Insulin/glucose ratio30 minutesRatio between insulin and glucose in blood as measured at 30 minutes after start of test product intake
Ad libitum meal4 hoursWeight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026