- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819972
The Dose Response of Calcium Co-ingested With Protein on GLP-1 Concentrations (PROCAL)
The Dose Response of Milk Minerals High in Calcium With Protein on Plasma Glucagon-Like Peptide-1 Concentrations
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Somerset
-
Bath, Somerset, United Kingdom, BA2 7AY
- Department for Health, University of Bath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
Participants will ingest a drink containing 25 g whey protein hydrolysate (227 mg of total calcium ingested)
|
Capolac® (milk minerals high in calcium) dose is manipulated
|
ACTIVE_COMPARATOR: Dose 1
Participants will ingest a drink containing 25 g whey protein hydrolysate and 3179 mg Capolac (984 mg of total calcium ingested)
|
Capolac® (milk minerals high in calcium) dose is manipulated
|
ACTIVE_COMPARATOR: Dose 2
Participants will ingest a drink containing 25 g whey protein hydrolysate and 6363 mg Capolac (1742 mg of total calcium ingested)
|
Capolac® (milk minerals high in calcium) dose is manipulated
|
ACTIVE_COMPARATOR: Dose 3
Participants will ingest a drink containing 25 g whey protein hydrolysate and 9547 mg Capolac (2500 mg of total calcium ingested)
|
Capolac® (milk minerals high in calcium) dose is manipulated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total plasma glucagon-like peptide-1 concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active plasma glucagon-like peptide-1 concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Plasma insulin concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Plasma NEFA concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Plasma albumin concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Serum calcium concentrations
Time Frame: 4 hours
|
Blood sampling
|
4 hours
|
Subjective appetite
Time Frame: 4 hours
|
Visual appetite scales
|
4 hours
|
ad libitum food intake
Time Frame: 4 hours
|
lunch meal
|
4 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PROCAL-JW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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