Healthy Adult VolunteersNCT05154461
Intestinal Ketone Bodies Interfere With the Glycemic Control
A study testing Alginate and Pea-protein in people with Healthy Adult Volunteers, run by Göteborg University at 1 site in Sweden.
Trial summary
The ketone body (KB) ß-hydroxybutyrate will be given to eight fasting healthy volunteers of both sexes in order to observe the effects after an oral glucose tolerance test (OGTT) over 2 h. Then, a standard lunch will be served at 12.00, as well as an afternoon snack at 15.00. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Alginate and Pea-protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 5 Dec 2021to 1 Sep 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of both sexes
- healthy and without prescribed pharmaceuticals (anticonceptive drugs allowed)
- no symptoms associated with gastrointestinal dysfunction
Who cannot join
- pregnancy or breastfeeding
- allergy towards standard meals or treatment
- previous substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Gothenburg, SE41345
About this study
Official title: Intestinal Ketogenic Inhibition of the Incretin GLP-1
The ketone body (KB) ß-hydroxybutyrate will be given to eight fasting healthy volunteers of both sexes in order to observe the effects after an oral glucose tolerance test (OGTT) over 2 h. Then, a standard lunch will be served at 12.00, as well as an afternoon snack at 15.00. Each participant will be its own control and participates in a randomised two-way cross over design; the KB are released in the stomach-duodenum, or in the ileum-colon. Peripheral blood samples are taken for endpoint GLP-1 analyses.
Read the detailed description
It has been shown in man that a fatty diet in people with obesity stimulated the release of ketone bodies (KB) in the small intestinal mucosa. This observation was partly explained by an increased level of the ketogenic enzyme 3-hydroxy-3-methylglutaryl-CoA synthase (HMGCS2) in the jejunum of the obese people.
Glucagon-like peptide 1 (GLP-1) is a peptide that is released from the intestinal mucosa and mediates among other things, satiation, as well as insulin-secretion and insulin-sensitivity. In patients with obesity, GLP-1 response to food is attenuated, but it increases following bariatric surgery.
The question arose if the increased KB could be linked to the decreased level of meal-induced GLP-1. Indeed, in mice and rats the increased production of KB could be related to a decreased level of GLP-1. However, such a close relationship has never been shown in man.
The present study tests, therefore, if release of the ketone body beta-hydroxybutyric acid into the intestine on two levels (stomach/duodenum and ileum/colon) of healthy volunteers influences the blood concentration of GLP-1 following an oral glucose tolerance test (OGTT). Glucose, insulin and KB are determined in peripheral plasma according to OGTT-routine.
KB are lipid-derived organic molecules that can serve a circulating energy source during starvation/fasting (or pronged exercise). Beta-hydroxybutyrate (BHB), acetoacetate (AcAc) and acetone ("ketone bodies") are products of acetyl-CoA derived from fatty acids converted to via hepatic mitochondria. The three KB are connected to each by proteolytic interconnection. BHB is the most important source of energy, while AcAc is approximately 25-30% of BHB. Acetone is gas-soluble and is exhaled if ketonemia increases.
The present study utilises ingestion of one KB (BHB) to get an acute, rapid increase in ketonemia. An encapsulation technology is used to differentiate the effect of KB on the small intestine from the effect mainly in the colon. Microcapsules with 1./ alginate, will release the KB in proximal stomach/duodenal intestine, and 2./ pea protein will release in the distal part of the intestine, mainly colon. The microcapsules are of food grade and are produced according to Good Manufacturing Process (GMP) standards (AnaBio Technologies LTD, Cork, Ireland). The KB in the microcapsules will contain 18 g BHB- and Ca+, Mg2+. Together with the encapsulation material (alginate or pea-protein) the total weight will be 20g per dose.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Alginate, Pea-protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlginateOther
BHB covered in alginate will be realised in stomach-duodenum
Pea-proteinOther
BHB covered in pea-protein will be released in ileum-colon
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 in relation to the 2 major BHB release sites | Experimental | The magnitude of plasma GLP-1 following an OGTT (75g glucose per os) when beta-hydroxybutyrate (BHB) is released either at an upper gastrointestinal site (alginate encapsulation), or at distal gastrointestinal site (pea-protein encapsulation). BHB is given per-os in a single dose of 18g, plus 2 g encapsulation material; totally 20 g. Receives: Other: Alginate; Other: Pea-protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of plasma GLP-1 over 120 minutes.
BHB is given in the upper GI tract (alginate encapsulation) or at the distal GI tract (pea-protein encapsulated). AUC of the plasma GLP-1 concentration (pmol x min) stimulated by an OGTT (75 g glucose per-os given).
Measured: 120 minutes (AUC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start5 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Fändriks, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154461
- Sponsor's protocol ID
- Ket001
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Informed Consent Form will be delivered to the study personnel.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Ketogenic Inhibition of the Incretin GLP-1
- ClinicalTrials.gov ID
- NCT05154461
- Acronym / sponsor ID
- Ket001
- Conditions
- Healthy Adult Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 13 Dec 2021 (actual)
- 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 ketone body (KB) ß-hydroxybutyrate will be given to eight fasting healthy volunteers of both sexes in order to observe the effects after an oral glucose tolerance test (OGTT) over 2 h. Then, a standard lunch will be served at 12.00, as well as an afternoon snack at 15.00. Each participant will be its own control and participates in a randomised two-way cross over design; the KB are released in the stomach-duodenum, or in the ileum-colon. Peripheral blood samples are taken for endpoint GLP-1 analyses.
Detailed description
It has been shown in man that a fatty diet in people with obesity stimulated the release of ketone bodies (KB) in the small intestinal mucosa. This observation was partly explained by an increased level of the ketogenic enzyme 3-hydroxy-3-methylglutaryl-CoA synthase (HMGCS2) in the jejunum of the obese people.
Glucagon-like peptide 1 (GLP-1) is a peptide that is released from the intestinal mucosa and mediates among other things, satiation, as well as insulin-secretion and insulin-sensitivity. In patients with obesity, GLP-1 response to food is attenuated, but it increases following bariatric surgery.
The question arose if the increased KB could be linked to the decreased level of meal-induced GLP-1. Indeed, in mice and rats the increased production of KB could be related to a decreased level of GLP-1. However, such a close relationship has never been shown in man.
The present study tests, therefore, if release of the ketone body beta-hydroxybutyric acid into the intestine on two levels (stomach/duodenum and ileum/colon) of healthy volunteers influences the blood concentration of GLP-1 following an oral glucose tolerance test (OGTT). Glucose, insulin and KB are determined in peripheral plasma according to OGTT-routine.
KB are lipid-derived organic molecules that can serve a circulating energy source during starvation/fasting (or pronged exercise). Beta-hydroxybutyrate (BHB), acetoacetate (AcAc) and acetone ("ketone bodies") are products of acetyl-CoA derived from fatty acids converted to via hepatic mitochondria. The three KB are connected to each by proteolytic interconnection. BHB is the most important source of energy, while AcAc is approximately 25-30% of BHB. Acetone is gas-soluble and is exhaled if ketonemia increases.
The present study utilises ingestion of one KB (BHB) to get an acute, rapid increase in ketonemia. An encapsulation technology is used to differentiate the effect of KB on the small intestine from the effect mainly in the colon. Microcapsules with 1./ alginate, will release the KB in proximal stomach/duodenal intestine, and 2./ pea protein will release in the distal part of the intestine, mainly colon. The microcapsules are of food grade and are produced according to Good Manufacturing Process (GMP) standards (AnaBio Technologies LTD, Cork, Ireland). The KB in the microcapsules will contain 18 g BHB- and Ca+, Mg2+. Together with the encapsulation material (alginate or pea-protein) the total weight will be 20g per dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 in relation to the 2 major BHB release sites | Experimental | Other: Alginate, Other: Pea-proteinThe magnitude of plasma GLP-1 following an OGTT (75g glucose per os) when beta-hydroxybutyrate (BHB) is released either at an upper gastrointestinal site (alginate encapsulation), or at distal gastrointestinal site (pea-protein encapsulation). BHB is given per-os in a single dose of 18g, plus 2 g encapsulation material; totally 20 g. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of both sexes
- healthy and without prescribed pharmaceuticals (anticonceptive drugs allowed)
- no symptoms associated with gastrointestinal dysfunction
Key exclusion criteria (3 listed)
- pregnancy or breastfeeding
- allergy towards standard meals or treatment
- previous substance abuse
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 |
|---|---|---|
| AlginateBHB covered in alginate will be realised in stomach-duodenum | Other | GLP-1 in relation to the 2 major BHB release sites |
| Pea-proteinBHB covered in pea-protein will be released in ileum-colon | Other | GLP-1 in relation to the 2 major BHB release sites |
Primary outcome
Area under curve (AUC) of plasma GLP-1 over 120 minutes.
Time frame: 120 minutes (AUC)
BHB is given in the upper GI tract (alginate encapsulation) or at the distal GI tract (pea-protein encapsulated). AUC of the plasma GLP-1 concentration (pmol x min) stimulated by an OGTT (75 g glucose per-os given).
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 30 Sep 2022.
- Individual participant dataSharing planned: Yes. Study Protocol and Informed Consent Form will be delivered to the study personnel.
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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.
Lars Fändriks, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alginate and Pea-protein in people with Healthy Adult Volunteers, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 3 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 30 Sep 2022. 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 Sweden. 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. 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?
Area under curve (AUC) of plasma GLP-1 over 120 minutes. (time frame: 120 minutes (AUC)). 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 30 Sep 2022.