ObesityNCT03232034
Calcium, Protein and Gut Hormones
A study testing Calcium Citrate, Milk Mineral Supplement and Whey Protein Hydrolysate in people with Obesity and Diabetes, run by University of Bath at 1 site in United Kingdom.
Trial summary
Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Calcium Citrate, Milk Mineral Supplement and Whey Protein Hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 31 Jan 2018
- 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
- Healthy men and women age between 18-65 yrs.
- Able to consume provided supplement.
- Weigh stable for the past 3 month (no change within 3%).
Who cannot join
- Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
- Not between the ages of 18-65 years
- A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
- Taking medications that may influence your metabolism
- Plans to change your lifestyle (diet and/or physical activity) during the study period
- Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion
Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.
Read the detailed description
Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).
Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.
- Being tested
- Calcium Citrate, Milk Mineral Supplement, Whey Protein Hydrolysate
- Keywords
- Calcium citrate, dairy product, whey protein, appetite, metabolism
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CitrateDietary supplement
1000 mg calcium as calcium citrate
Milk Mineral SupplementDietary supplement
Milk Minerals containing 1000 mg calcium
Whey Protein HydrolysateDietary supplement
50 g whey protein hydrolysate
| Study group | Role | What they receive |
|---|---|---|
| Calcium Citrate | Placebo comparator | Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. Receives: Dietary Supplement: Calcium Citrate |
| Milk Mineral Supplement | Active comparator | Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. Receives: Dietary Supplement: Milk Mineral Supplement |
| Milk mineral supplement plus Whey Protein Hydrolysate | Experimental | Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. Receives: Dietary Supplement: Milk Mineral Supplement; Dietary Supplement: Whey Protein Hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
Plasma glucagon-like peptide-1 (GLP-1) concentrations
Measured: 120 min
Secondary outcomes (6)
Postprandial plasma GIP area under the curve (mmol/L x 120 min)
Plasma glucose-dependent insulinotropic peptide (GIP) concentrations
Measured: 120 min
Postprandial plasma PYY area under the curve (mmol/L x 120 min)
Plasma peptide tyrosine tyrosine (PYY) concentrations.
Measured: 120 min
Subjective ratings of appetite (au)
Visual analogue scales of appetite ratings
Measured: 120 min
Energy metabolism (carbohydrate and fat oxidation)
Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry
Measured: 120 min
Postprandial plasma glucose
Plasma glucose concentrations (mmol/L).
Measured: 120 min
Blood pressure
Systolic and diastolic blood pressure
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 May 2017
- Primary completion5 Dec 2017
- Study completion31 Jan 2018
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 ObesityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232034
- Sponsor's protocol ID
- REACH EP 16/17_164
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.
PubMed 31531707
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion
- ClinicalTrials.gov ID
- NCT03232034
- Acronym / sponsor ID
- REACH EP 16/17_164
- Keywords
- Calcium citrate, dairy product, whey protein, appetite, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 27 Jul 2017 (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.
Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.
Detailed description
Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).
Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Citrate | Placebo comparator | Dietary Supplement: Calcium CitrateCalcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. |
| Milk Mineral Supplement | Active comparator | Dietary Supplement: Milk Mineral SupplementMilk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. |
| Milk mineral supplement plus Whey Protein Hydrolysate | Experimental | Dietary Supplement: Milk Mineral Supplement, Dietary Supplement: Whey Protein HydrolysateMilk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women age between 18-65 yrs.
- Able to consume provided supplement.
- Weigh stable for the past 3 month (no change within 3%).
Key exclusion criteria (7 listed)
- Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
- Not between the ages of 18-65 years
- A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
- Taking medications that may influence your metabolism
- Plans to change your lifestyle (diet and/or physical activity) during the study period
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 |
|---|---|---|
| Calcium Citrate1000 mg calcium as calcium citrate | Dietary supplement | Calcium Citrate |
| Milk Mineral SupplementMilk Minerals containing 1000 mg calcium | Dietary supplement | Milk Mineral Supplement, Milk mineral supplement plus Whey Protein Hydrolysate |
| Whey Protein Hydrolysate50 g whey protein hydrolysate | Dietary supplement | Milk mineral supplement plus Whey Protein Hydrolysate |
Primary outcome
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
Time frame: 120 min
Plasma glucagon-like peptide-1 (GLP-1) concentrations
6 secondary outcomes
Postprandial plasma GIP area under the curve (mmol/L x 120 min)
Time frame: 120 min
Postprandial plasma PYY area under the curve (mmol/L x 120 min)
Time frame: 120 min
Subjective ratings of appetite (au)
Time frame: 120 min
Energy metabolism (carbohydrate and fat oxidation)
Time frame: 120 min
Postprandial plasma glucose
Time frame: 120 min
Blood pressure
Time frame: 120 min
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 Aug 2018.
- Derived from this study: PubMed 31531707Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.
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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.
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 Calcium Citrate, Milk Mineral Supplement and Whey Protein Hydrolysate in people with Obesity and Diabetes, 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 3 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 Aug 2018. 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?
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min). (time frame: 120 min). 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 NCT03232034, 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 Aug 2018.