Insulin ResistanceFooA2NCT01999504
Gut Hormone Response After Paleolithic-type Meals
A study testing PAL-2, TFH-1 and Reference in people with Insulin Resistance and Satiety, run by Unilever R&D at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Satiety
- What is being tested?
- PAL-2, TFH-1 and Reference
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Leatherhead Food Research
Leatherhead, Surrey, KT22 7RY
About this study
Official title: Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
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
Read the 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.
- Conditions
- Insulin Resistance, Satiety
- Being tested
- PAL-2, TFH-1, Reference
- Keywords
- Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAL-2Other
meal
TFH-1Other
Meal
ReferenceOther
Meal
| Study group | Role | What they receive |
|---|---|---|
| PAL-2 | Experimental | 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). Receives: Other: PAL-2 |
| TFH-1 | Experimental | 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). Receives: Other: TFH-1 |
| Reference | Placebo comparator | Meal based on WHO dietary guidelines for protein, fat and carbohydrate. Receives: Other: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon-like peptide-1
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
Measured: 0-3 hours
Secondary outcomes (8)
Glucose-dependent Insulinotropic Peptide
Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma
Measured: 0-3 hours
Fullness
Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time
Measured: 0-4 hours
Glucose
Area under the Concentration versus time curve of Glucose in blood
Measured: 0-3 hours
Insulin
Area under the Concentration versus time curve of insulin in blood plasma
Measured: 0-3 hours
Glucagon
Area under the Concentration versus time curve of Glucagon in blood plasma
Measured: 0-3 hours
Peptide YY
Area under the Concentration versus time curve of Peptide YY in blood plasma
Measured: 0-3 hours
Hunger
Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time
Measured: 0-4 hours
Desire to eat
Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leatherhead Food Research
- Responsible party
- Sponsor
- Investigators
- Carmen Diaz-Toledo Trenado, Principal investigator, Leatherhead Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999504
- Sponsor's protocol ID
- FDS-BNH-1268
- Acronym
- FooA2
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2013
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
- ClinicalTrials.gov ID
- NCT01999504
- Acronym / sponsor ID
- FooA2 / FDS-BNH-1268
- Conditions
- Insulin Resistance, Satiety
- Keywords
- Glucagon-like peptide-1, Glucose-dependent Insulinotropic Peptide, Peptide YY, Glucagon, Satiety, Meal, palaeolithic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Leatherhead Food Research
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAL-2 | Experimental | Other: PAL-2Based 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). |
| TFH-1 | Experimental | Other: TFH-1Based 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). |
| Reference | Placebo comparator | Other: ReferenceMeal based on WHO dietary guidelines for protein, fat and carbohydrate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAL-2meal | Other | PAL-2 |
| TFH-1Meal | Other | TFH-1 |
| ReferenceMeal | Other | Reference |
Primary outcome
Glucagon-like peptide-1
Time frame: 0-3 hours
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
8 secondary outcomes
Glucose-dependent Insulinotropic Peptide
Time frame: 0-3 hours
Fullness
Time frame: 0-4 hours
Glucose
Time frame: 0-3 hours
Insulin
Time frame: 0-3 hours
Glucagon
Time frame: 0-3 hours
Peptide YY
Time frame: 0-3 hours
Hunger
Time frame: 0-4 hours
Desire to eat
Time frame: 0-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Diaz-Toledo Trenado principal investigator
Leatherhead Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAL-2, TFH-1 and Reference in people with Insulin Resistance and Satiety, run by Unilever R&D at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon-like peptide-1 (time frame: 0-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.