HealthyNCT01986036
The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake
A study testing Protein, Calcium and Porridge-based breakfast. in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Protein, Calcium and Porridge-based breakfast.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to May 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- BMI 18.5-29.9 kg/m2
- Age: 18-40 years
Who cannot join
- Smokers
- Food allergies
- Metabolic disorders (ie. type 2 diabetes)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations.
This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.
- Conditions
- Healthy
- Being tested
- Protein, Calcium, Porridge-based breakfast.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Milk-Protein
CalciumDietary supplement
Soluble calcium powder.
Porridge-based breakfast.Dietary supplement
Oats and water.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Sham comparator | Control breakfast low in protein and calcium. Porridge-based breakfast. Receives: Dietary Supplement: Porridge-based breakfast. |
| PROTEIN | Active comparator | High-protein breakfast. Receives: Dietary Supplement: Protein; Dietary Supplement: Porridge-based breakfast. |
| CALCIUM | Active comparator | High-calcium breakfast. Receives: Dietary Supplement: Calcium; Dietary Supplement: Porridge-based breakfast. |
| PRO-CAL | Experimental | High-protein and calcium breakfast. Receives: Dietary Supplement: Protein; Dietary Supplement: Calcium; Dietary Supplement: Porridge-based breakfast. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake
Energy intake will be assessed by ad libitum consumption of a homogenous pasta meal, 1 h after the test-meal.
Measured: 60 min post test-meal
Secondary outcomes (4)
Subjective appetite sensations
Subjective appetite sensations (hunger, satisfaction, prospective consumption and fullness) will be assessed by visual analogue scales at baseline, and every 15 min following test-meal consumption.
Measured: 1 hr
Insulin concentrations
Plasma insulin concentrations will be determined at baseline and every 15 min following test-meal consumption.
Measured: 1 hr
GLP-1 (7-36) concentrations
Plasma glucagon-like peptide-1 (GLP-1) (7-36) concentrations will be determined at baseline and every 15 min following consumption of the test meal.
Measured: 1 hr
GIP concentration
Plasma glucose-dependent insulinotropic peptide (GIP) concentrations will be determined at baseline and evert 15 min following test-meal consumption.
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, PhD, Northumbria University
- Investigators
- Javier T Gonzalez, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986036
- Sponsor's protocol ID
- 32AN4
- Status last verified
- Apr 2014
- First submitted
- 11 Nov 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Astbury NM, Stevenson EJ, Morris P, Taylor MA, Macdonald IA. Dose-response effect of a whey protein preload on within-day energy intake in lean subjects. Br J Nutr. 2010 Dec;104(12):1858-67. doi: 10.1017/S000711451000293X. Epub 2010 Sep 28.
PubMed 20875183Gonzalez JT, Rumbold PL, Stevenson EJ. Appetite sensations and substrate metabolism at rest, during exercise, and recovery: impact of a high-calcium meal. Appl Physiol Nutr Metab. 2013 Dec;38(12):1260-7. doi: 10.1139/apnm-2013-0056. Epub 2013 Jun 18.
PubMed 24195627Gonzalez JT, Stevenson EJ. Calcium co-ingestion augments postprandial glucose-dependent insulinotropic peptide(1-42), glucagon-like peptide-1 and insulin concentrations in humans. Eur J Nutr. 2014;53(2):375-85. doi: 10.1007/s00394-013-0532-8. Epub 2013 May 21.
PubMed 23689561Gonzalez JT, Green BP, Brown MA, Rumbold PL, Turner LA, Stevenson EJ. Calcium ingestion suppresses appetite and produces acute overcompensation of energy intake independent of protein in healthy adults. J Nutr. 2015 Mar;145(3):476-82. doi: 10.3945/jn.114.205708. Epub 2015 Jan 14.
PubMed 25733462
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake
- ClinicalTrials.gov ID
- NCT01986036
- Acronym / sponsor ID
- 32AN4
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 18 Nov 2013 (estimated)
- 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.
High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations.
This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Sham comparator | Dietary Supplement: Porridge-based breakfast.Control breakfast low in protein and calcium. Porridge-based breakfast. |
| PROTEIN | Active comparator | Dietary Supplement: Protein, Dietary Supplement: Porridge-based breakfast.High-protein breakfast. |
| CALCIUM | Active comparator | Dietary Supplement: Calcium, Dietary Supplement: Porridge-based breakfast.High-calcium breakfast. |
| PRO-CAL | Experimental | Dietary Supplement: Protein, Dietary Supplement: Calcium, Dietary Supplement: Porridge-based breakfast.High-protein and calcium breakfast. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or Female
- BMI 18.5-29.9 kg/m2
- Age: 18-40 years
Key exclusion criteria (3 listed)
- Smokers
- Food allergies
- Metabolic disorders (ie. type 2 diabetes)
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 |
|---|---|---|
| ProteinMilk-Protein | Dietary supplement | PRO-CAL, PROTEIN |
| CalciumSoluble calcium powder. | Dietary supplement | CALCIUM, PRO-CAL |
| Porridge-based breakfast.Oats and water. | Dietary supplement | CALCIUM, CONTROL, PRO-CAL, PROTEIN |
Primary outcome
Energy Intake
Time frame: 60 min post test-meal
Energy intake will be assessed by ad libitum consumption of a homogenous pasta meal, 1 h after the test-meal.
4 secondary outcomes
Subjective appetite sensations
Time frame: 1 hr
Insulin concentrations
Time frame: 1 hr
GLP-1 (7-36) concentrations
Time frame: 1 hr
GIP concentration
Time frame: 1 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Background: PubMed 20875183Astbury NM, Stevenson EJ, Morris P, Taylor MA, Macdonald IA. Dose-response effect of a whey protein preload on within-day energy intake in lean subjects. Br J Nutr. 2010 Dec;104(12):1858-67. doi: 10.1017/S000711451000293X. Epub 2010 Sep 28.
- Background: PubMed 24195627Gonzalez JT, Rumbold PL, Stevenson EJ. Appetite sensations and substrate metabolism at rest, during exercise, and recovery: impact of a high-calcium meal. Appl Physiol Nutr Metab. 2013 Dec;38(12):1260-7. doi: 10.1139/apnm-2013-0056. Epub 2013 Jun 18.
- Background: PubMed 23689561Gonzalez JT, Stevenson EJ. Calcium co-ingestion augments postprandial glucose-dependent insulinotropic peptide(1-42), glucagon-like peptide-1 and insulin concentrations in humans. Eur J Nutr. 2014;53(2):375-85. doi: 10.1007/s00394-013-0532-8. Epub 2013 May 21.
- Derived from this study: PubMed 25733462Gonzalez JT, Green BP, Brown MA, Rumbold PL, Turner LA, Stevenson EJ. Calcium ingestion suppresses appetite and produces acute overcompensation of energy intake independent of protein in healthy adults. J Nutr. 2015 Mar;145(3):476-82. doi: 10.3945/jn.114.205708. Epub 2015 Jan 14.
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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.
Javier T Gonzalez, PhD principal investigator
Northumbria 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 Protein, Calcium and Porridge-based breakfast. in people with Healthy, run by Northumbria University 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 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: status not confirmed, as of the sponsor's last update on 21 Apr 2014. 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?
Results are not available in the source record.
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?
Energy Intake (time frame: 60 min post test-meal). 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 NCT01986036, which also lists 4 linked publications.
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 21 Apr 2014.