GLP-1 ConcentrationPROCALNCT03819972
The Dose Response of Calcium Co-ingested With Protein on GLP-1 Concentrations
A study testing Dose response of Capolac® in people with GLP-1 Concentration, run by University of Bath at 1 site in United Kingdom.
Trial summary
Hormones that are produced by our stomach and intestines play a role in regulating our appetite and health. One of the most important hormones is called GLP-1. The food we eat influences the release of this hormone and evidence suggests that protein and calcium are key nutrients that stimulate the secretion of GLP-1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- GLP-1 Concentration
- What is being tested?
- Dose response of Capolac®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2019to 31 Mar 2021
- 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
- Body mass index 25.0-34.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
Who cannot join
- Allergies or adverse reactions to calcium or milk proteins.
- Contradictions to a high intake of calcium e.g. history of kidney stones
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, Somerset, BA2 7AY
About this study
Official title: The Dose Response of Milk Minerals High in Calcium With Protein on Plasma Glucagon-Like Peptide-1 Concentrations
Hormones that are produced by our stomach and intestines play a role in regulating our appetite and health. One of the most important hormones is called GLP-1. The food we eat influences the release of this hormone and evidence suggests that protein and calcium are key nutrients that stimulate the secretion of GLP-1. We want to know if there is a dose related response by increasing the amount of calcium ingested with a constant amount of protein on the release of this hormone. We hypothesise that with increasing calcium dose we will see an increase in GLP-1 concentrations in a curvilinear pattern. This may have benefits for prescribing an optimal dose of calcium for weight maintenance and health.
Read the detailed description
Recent work at the University of Bath has shown that when ingested with 50 g whey protein hydrolysate, Capolac® (milk minerals high in calcium) potently stimulates availability of the important hormone glucagon-like peptide-1 (GLP-1). However, it is currently unknown as to whether there is a dose dependent response to calcium co-ingestion with protein. Therefore we aim to perform a study on the effect of co-ingesting different doses of Capolac® with 25 g whey protein hydrolysate on GLP-1 availability. This project will help identify the calcium dose required with a moderate amount of protein to optimise GLP-1 availability and also provide insight into whether this may affect food intake and appetite.
Twenty metabolically healthy men and women, age 18-65 years, BMI between 25 and 34.9 kg/m2 will be recruited to participate in a randomised crossover study. Each participant will undergo 4 trials. Each trial will last ~4 hours and will be separated by a minimum of 48h:
- CONTROL - 25 g whey protein hydrolysate (227 mg of total calcium ingested)
- DOSE 1 - 25 g whey protein hydrolysate + 3179 mg Capolac (984 mg of total calcium ingested)
- DOSE 2 - 25 g whey protein hydrolysate + 6363 mg Capolac (1742 mg of total calcium ingested)
- DOSE 3 - 25 g whey protein hydrolysate + 9547 mg Capolac (2500 mg of total calcium ingested) Each of these drinks will also contain 500 mL of water and low calorie sweetener (80 mg sucralose).
Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 10-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Upon arrival at the laboratory a trained phlebotomist staff member will insert a cannula (a small plastic tube) into a vein in the back of the hand. Participants will then be given one of the four test drinks, which once ingested will initiate the trial. Just after the ingestion of the test drink we will ask you to fill out a palatability scale.
Blood samples will be taken at baseline, and at 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion of the test drink. An appetite questionnaire will also be completed at baseline and every 60 minutes after ingestion of the test drink to assess appetite sensations. After the 180-minute time point participants will be asked to consume a lunch meal until they are comfortably full. Once satisfied with the lunch meal they will fill out the final appetite questionnaire. The trial day will then be complete. Following study completion participants will be asked to complete a restrained eating questionnaire.
- Conditions
- GLP-1 Concentration
- Being tested
- Dose response of Capolac®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose response of Capolac®Dietary supplement
Capolac® (milk minerals high in calcium) dose is manipulated
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will ingest a drink containing 25 g whey protein hydrolysate (227 mg of total calcium ingested) Receives: Dietary Supplement: Dose response of Capolac® |
| Dose 1 | Active comparator | Participants will ingest a drink containing 25 g whey protein hydrolysate and 3179 mg Capolac (984 mg of total calcium ingested) Receives: Dietary Supplement: Dose response of Capolac® |
| Dose 2 | Active comparator | Participants will ingest a drink containing 25 g whey protein hydrolysate and 6363 mg Capolac (1742 mg of total calcium ingested) Receives: Dietary Supplement: Dose response of Capolac® |
| Dose 3 | Active comparator | Participants will ingest a drink containing 25 g whey protein hydrolysate and 9547 mg Capolac (2500 mg of total calcium ingested) Receives: Dietary Supplement: Dose response of Capolac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma glucagon-like peptide-1 concentrations
Blood sampling
Measured: 4 hours
Secondary outcomes (7)
Active plasma glucagon-like peptide-1 concentrations
Blood sampling
Measured: 4 hours
Plasma insulin concentrations
Blood sampling
Measured: 4 hours
Plasma NEFA concentrations
Blood sampling
Measured: 4 hours
Plasma albumin concentrations
Blood sampling
Measured: 4 hours
Serum calcium concentrations
Blood sampling
Measured: 4 hours
Subjective appetite
Visual appetite scales
Measured: 4 hours
ad libitum food intake
lunch meal
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start2 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GLP-1 ConcentrationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are 4 conditions where participants will ingest differing amounts of calcium in a randomised order
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Principal investigator, Jonathan Watkins, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819972
- Sponsor's protocol ID
- PROCAL-JW
- Acronym
- PROCAL
- Status last verified
- Apr 2021
- First submitted
- 21 Jan 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watkins JD, Smith HA, Hengist A, Brunsgaard LH, Mikkelsen UR, Koumanov F, Betts JA, Gonzalez JT. Plasma glucagon-like peptide-1 responses to ingestion of protein with increasing doses of milk minerals rich in calcium. Br J Nutr. 2022 Jul 14;128(1):55-63. doi: 10.1017/S000711452100297X. Epub 2021 Aug 9.
PubMed 34369333
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Response of Milk Minerals High in Calcium With Protein on Plasma Glucagon-Like Peptide-1 Concentrations
- ClinicalTrials.gov ID
- NCT03819972
- Acronym / sponsor ID
- PROCAL / PROCAL-JW
- Conditions
- GLP-1 Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Jan 2019 (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.
Hormones that are produced by our stomach and intestines play a role in regulating our appetite and health. One of the most important hormones is called GLP-1. The food we eat influences the release of this hormone and evidence suggests that protein and calcium are key nutrients that stimulate the secretion of GLP-1. We want to know if there is a dose related response by increasing the amount of calcium ingested with a constant amount of protein on the release of this hormone. We hypothesise that with increasing calcium dose we will see an increase in GLP-1 concentrations in a curvilinear pattern. This may have benefits for prescribing an optimal dose of calcium for weight maintenance and health.
Detailed description
Recent work at the University of Bath has shown that when ingested with 50 g whey protein hydrolysate, Capolac® (milk minerals high in calcium) potently stimulates availability of the important hormone glucagon-like peptide-1 (GLP-1). However, it is currently unknown as to whether there is a dose dependent response to calcium co-ingestion with protein. Therefore we aim to perform a study on the effect of co-ingesting different doses of Capolac® with 25 g whey protein hydrolysate on GLP-1 availability. This project will help identify the calcium dose required with a moderate amount of protein to optimise GLP-1 availability and also provide insight into whether this may affect food intake and appetite.
Twenty metabolically healthy men and women, age 18-65 years, BMI between 25 and 34.9 kg/m2 will be recruited to participate in a randomised crossover study. Each participant will undergo 4 trials. Each trial will last ~4 hours and will be separated by a minimum of 48h:
- CONTROL - 25 g whey protein hydrolysate (227 mg of total calcium ingested)
- DOSE 1 - 25 g whey protein hydrolysate + 3179 mg Capolac (984 mg of total calcium ingested)
- DOSE 2 - 25 g whey protein hydrolysate + 6363 mg Capolac (1742 mg of total calcium ingested)
- DOSE 3 - 25 g whey protein hydrolysate + 9547 mg Capolac (2500 mg of total calcium ingested) Each of these drinks will also contain 500 mL of water and low calorie sweetener (80 mg sucralose).
Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 10-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Upon arrival at the laboratory a trained phlebotomist staff member will insert a cannula (a small plastic tube) into a vein in the back of the hand. Participants will then be given one of the four test drinks, which once ingested will initiate the trial. Just after the ingestion of the test drink we will ask you to fill out a palatability scale.
Blood samples will be taken at baseline, and at 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion of the test drink. An appetite questionnaire will also be completed at baseline and every 60 minutes after ingestion of the test drink to assess appetite sensations. After the 180-minute time point participants will be asked to consume a lunch meal until they are comfortably full. Once satisfied with the lunch meal they will fill out the final appetite questionnaire. The trial day will then be complete. Following study completion participants will be asked to complete a restrained eating questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- There are 4 conditions where participants will ingest differing amounts of calcium in a randomised order
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Dose response of Capolac®Participants will ingest a drink containing 25 g whey protein hydrolysate (227 mg of total calcium ingested) |
| Dose 1 | Active comparator | Dietary Supplement: Dose response of Capolac®Participants will ingest a drink containing 25 g whey protein hydrolysate and 3179 mg Capolac (984 mg of total calcium ingested) |
| Dose 2 | Active comparator | Dietary Supplement: Dose response of Capolac®Participants will ingest a drink containing 25 g whey protein hydrolysate and 6363 mg Capolac (1742 mg of total calcium ingested) |
| Dose 3 | Active comparator | Dietary Supplement: Dose response of Capolac®Participants will ingest a drink containing 25 g whey protein hydrolysate and 9547 mg Capolac (2500 mg of total calcium ingested) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index 25.0-34.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
Key exclusion criteria (7 listed)
- Allergies or adverse reactions to calcium or milk proteins.
- Contradictions to a high intake of calcium e.g. history of kidney stones
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
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 |
|---|---|---|
| Dose response of Capolac®Capolac® (milk minerals high in calcium) dose is manipulated | Dietary supplement | Control, Dose 1, Dose 2, Dose 3 |
Primary outcome
Total plasma glucagon-like peptide-1 concentrations
Time frame: 4 hours
Blood sampling
7 secondary outcomes
Active plasma glucagon-like peptide-1 concentrations
Time frame: 4 hours
Plasma insulin concentrations
Time frame: 4 hours
Plasma NEFA concentrations
Time frame: 4 hours
Plasma albumin concentrations
Time frame: 4 hours
Serum calcium concentrations
Time frame: 4 hours
Subjective appetite
Time frame: 4 hours
ad libitum food intake
Time frame: 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 28 Apr 2021.
- Derived from this study: PubMed 34369333Watkins JD, Smith HA, Hengist A, Brunsgaard LH, Mikkelsen UR, Koumanov F, Betts JA, Gonzalez JT. Plasma glucagon-like peptide-1 responses to ingestion of protein with increasing doses of milk minerals rich in calcium. Br J Nutr. 2022 Jul 14;128(1):55-63. doi: 10.1017/S000711452100297X. Epub 2021 Aug 9.
- Individual participant dataSharing planned: No
Related trials for GLP-1 Concentration
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Active, not recruitingPhase 1/2
Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults
Obesity and Overweight, Appetite Regulation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose response of Capolac® in people with GLP-1 Concentration, run by University of Bath 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 5 inclusion and 7 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 28 Apr 2021. 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?
Total plasma glucagon-like peptide-1 concentrations (time frame: 4 hours). 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 NCT03819972, which also lists 1 linked publication.
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 28 Apr 2021.