ObesityNCT03370484
Calcium and Gut Hormones
A study testing Milk mineral supplement 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). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Milk mineral supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 28 Feb 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.
- Weight 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.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: The Effect of Calcium Ingestion on Gut Hormone Secretion.
Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.
- Being tested
- Control, Milk mineral supplement
- 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.
ControlDietary supplement
Water with 80 mg sucralose
Milk mineral supplementDietary supplement
Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Water with artificial sweetener Receives: Dietary Supplement: Control |
| Milk mineral supplement | Experimental | Milk Minerals containing 1000 mg calcium with artificial sweetener and water Receives: Dietary Supplement: Milk mineral supplement |
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).
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
Measured: 120 min
Secondary outcomes (3)
Postprandial plasma GIP area under the curve (mmol/L x 120 min)
Postprandial plasma GIP area under the curve (mmol/L x 120 min)
Measured: 120 min
Postprandial plasma PYY area under the curve (mmol/L x 120 min)
Postprandial plasma PYY area under the curve (mmol/L x 120 min)
Measured: 120 min
Subjective ratings of appetite (au)
Subjective ratings of appetite (au)
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 posted12 Dec 2017
- Study start1 Oct 2017
- Primary completion31 Jan 2018
- Study completion28 Feb 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 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
- NCT03370484
- Sponsor's protocol ID
- REACH EP 16/17_164C
- Status last verified
- Aug 2018
- First submitted
- 6 Dec 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share anonymised data in publication form
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 Effect of Calcium Ingestion on Gut Hormone Secretion.
- ClinicalTrials.gov ID
- NCT03370484
- Acronym / sponsor ID
- REACH EP 16/17_164C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Dec 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). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlWater with artificial sweetener |
| Milk mineral supplement | Experimental | Dietary Supplement: Milk mineral supplementMilk Minerals containing 1000 mg calcium with artificial sweetener and water |
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.
- Weight 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 |
|---|---|---|
| ControlWater with 80 mg sucralose | Dietary supplement | Control |
| Milk mineral supplementWater with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose | Dietary supplement | Milk mineral supplement |
Primary outcome
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
Time frame: 120 min
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
3 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
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.
- Individual participant dataSharing planned: No. Share anonymised data in publication form
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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 Milk mineral supplement 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 NCT03370484, 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.