Glycemic Index of a MealNCT01418573
Glycemic Response After Palaeolithic-type Meals
A study testing Palaeolithic meal 1, Palaeolithic meal 2 and Reference meal in people with Glycemic Index of a Meal, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO 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
- Glycemic Index of a Meal
- What is being tested?
- Palaeolithic meal 1, Palaeolithic meal 2 and Reference meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Oct 2011
- 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
- male
- ≥ 18 and ≤ 60 years old
- Body mass index (BMI) ≥ 18 and ≤ 27.0 kg/m2
- Apparently healthy
- Not smoking
- A fasting blood glucose value within the normal reference value
Who cannot join
- No prescribed medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leatherhead Food Research
Leatherhead, Surrey, KT22 7RY
About this study
Official title: Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO dietary recommendations.
Read the detailed description
The effects of this set of meals will be assessed with respect to blood
- blood glucose
- plasma insulin
- satiety scores
- plasma gut hormones It is hypothesised that lower post prandial blood glucose concentration, a lower insulin response and increased satiety will be seen after the Palaeolithic meals compared with a reference meal
- Conditions
- Glycemic Index of a Meal
- Being tested
- Palaeolithic meal 1, Palaeolithic meal 2, Reference meal
- Keywords
- glucose, insulin, post prandial
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palaeolithic meal 1Other
Based on estimated ratios for protein, fat and carbohydrates that are typical of Hunter-Gatherers and does not contain ingredients that were not available in pre-neolithic times
Palaeolithic meal 2Other
Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times
Reference mealOther
Based on WHO dietary guidelines for protein, fat and carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| Palaeolithic-type meal 1 | Experimental | Not described Receives: Other: Palaeolithic meal 1 |
| Palaeolithic-type meal 2 | Experimental | Not described Receives: Other: Palaeolithic meal 2 |
| The reference meal | Placebo comparator | Not described Receives: Other: Reference meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
positive incremental area under the concentration versus time
Measured: 0-2 hours
Plasma insulin
net incremental area under the curve
Measured: 0-2 hours
Peak blood glucose
maximal blood glucose value
Measured: 0-2 hours
Secondary outcomes (2)
Satiety scores
area under the curve
Measured: 0-2 hours
Gut hormone panel
Average concentration over time
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glycemic Index of a MealStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- 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
- Sonia Pombo, Principal investigator, Leatherhead Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418573
- Sponsor's protocol ID
- FDS-BNH-0100
- Status last verified
- Feb 2012
- First submitted
- 16 Aug 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.
PubMed 19209185Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
PubMed 19604407Bligh HF, Godsland IF, Frost G, Hunter KJ, Murray P, MacAulay K, Hyliands D, Talbot DC, Casey J, Mulder TP, Berry MJ. Plant-rich mixed meals based on Palaeolithic diet principles have a dramatic impact on incretin, peptide YY and satiety response, but show little effect on glucose and insulin homeostasis: an acute-effects randomised study. Br J Nutr. 2015 Feb 28;113(4):574-84. doi: 10.1017/S0007114514004012. Epub 2015 Feb 9.
PubMed 25661189
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response After Two Palaeolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
- ClinicalTrials.gov ID
- NCT01418573
- Acronym / sponsor ID
- FDS-BNH-0100
- Conditions
- Glycemic Index of a Meal
- Keywords
- glucose, insulin, post prandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Leatherhead Food Research
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Aug 2011 (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 objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO dietary recommendations.
Detailed description
The effects of this set of meals will be assessed with respect to blood
- blood glucose
- plasma insulin
- satiety scores
- plasma gut hormones It is hypothesised that lower post prandial blood glucose concentration, a lower insulin response and increased satiety will be seen after the Palaeolithic meals compared with a reference meal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palaeolithic-type meal 1 | Experimental | Other: Palaeolithic meal 1 |
| Palaeolithic-type meal 2 | Experimental | Other: Palaeolithic meal 2 |
| The reference meal | Placebo comparator | Other: Reference meal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male
- ≥ 18 and ≤ 60 years old
- Body mass index (BMI) ≥ 18 and ≤ 27.0 kg/m2
- Apparently healthy
- Not smoking
Key exclusion criteria (1 listed)
- No prescribed medication
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 |
|---|---|---|
| Palaeolithic meal 1Based on estimated ratios for protein, fat and carbohydrates that are typical of Hunter-Gatherers and does not contain ingredients that were not available in pre-neolithic times | Other | Palaeolithic-type meal 1 |
| Palaeolithic meal 2Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times | Other | Palaeolithic-type meal 2 |
| Reference mealBased on WHO dietary guidelines for protein, fat and carbohydrate. | Other | The reference meal |
Primary outcome
Blood glucose
Time frame: 0-2 hours
positive incremental area under the concentration versus time
Plasma insulin
Time frame: 0-2 hours
net incremental area under the curve
Peak blood glucose
Time frame: 0-2 hours
maximal blood glucose value
2 secondary outcomes
Satiety scores
Time frame: 0-2 hours
Gut hormone panel
Time frame: 0-3 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 13 Aug 2013.
- Background: PubMed 19209185Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.
- Background: PubMed 19604407Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
- Derived from this study: PubMed 25661189Bligh HF, Godsland IF, Frost G, Hunter KJ, Murray P, MacAulay K, Hyliands D, Talbot DC, Casey J, Mulder TP, Berry MJ. Plant-rich mixed meals based on Palaeolithic diet principles have a dramatic impact on incretin, peptide YY and satiety response, but show little effect on glucose and insulin homeostasis: an acute-effects randomised study. Br J Nutr. 2015 Feb 28;113(4):574-84. doi: 10.1017/S0007114514004012. Epub 2015 Feb 9.
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.
Sonia Pombo 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 Palaeolithic meal 1, Palaeolithic meal 2 and Reference meal in people with Glycemic Index of a Meal, 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 6 inclusion and 1 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 13 Aug 2013. 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?
Blood glucose (time frame: 0-2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418573, which also lists 3 linked publications.
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 13 Aug 2013; AzTrials last refreshed its copy on 27 Oct 2026.