Prevention of ObesityPROKANCT01561131
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
A study testing Whey protein, Whey protein enriched with calcium and Soy protein in people with Prevention of Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Obesity
- What is being tested?
- Whey protein, Whey protein enriched with calcium and Soy protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Jan 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both men and women can be included
- All ethnic groups can be included
- Age: 18≤age≤60
- BMI: 28≤BMI≤40
Who cannot join
- smoking
- use of cholesterol-lowering medications or other medications considered to be of importance for participation in the trial
- use of special diets (eg. Atkins, vegetarian) within 2 months before the start of the project.
- elite athletes or if subjecct is planning to become elite athlete (e.g. Planning major changes in physical activity during the experiment).
- blood donation within the last 3 months before the commencement of the trial
- weight change> 3 kg within 2 months before the start of the project
Show all 24Show fewer
- sagital height of 32 cm
- pregnant or nursing women or women planning to become pregnant within the next 12 months.
- surgically treated obesity
- participation in other clinical trials within the last 3 months
- if consuming medicine daily, consumption of prescription medicine needs to have been stable through at least the last 3 months and is expected to remain so throughout the whole study. However, a subject cannot be included if the treatment includes medicine that is a systemic treatment that is considered to be of importance for participation in the project.
- alcohol or drug use (based on clinical judgment)
- subjects who are unable to give an informed consent.
- chronic systemic infectious or inflammatory disorders
- chronic endocrine disorders
- inadequate nutrient uptake, or chronic gastrointestinal or liver diseases (apart from irritable bowel disorder)
- cardiovascular disease, recognized heart failure or brain disease
- cancer within the past 10 years
- subject who is judged unable to participate in an LCD (low calorie diet) in an 8 week period
- known allergy to para-aminobenzoic acid (PABA)
- subjects who are in a general physical and/or mental condition,where the researcher assesses that the subject does not conform with the general aim of the study.
- subjects with a hemoglobin value below 7 mol / L. Those with a hemoglobin value below 8 mol / L (measured at screening) cannot volunteer for the meal test during hood measurements, but may be included in the main study.
- When starting on a weight maintenance period:
- persons during weight loss period, loss of <8% of their initial body weight
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, 1958
About this study
The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Furthermore, to examine short-term and long-term effect of a high protein intake on appetite regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on weightmaintence, bloodlipid profilen, appetite regulation and DIT.
The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight and composition will be measured and blood samples will be collected. Meal test will be performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces will be collected three times during the study. Subjects will receive dietary counseling (in groups) regularly during the study and body weight will be measured at each visit.
- Conditions
- Prevention of Obesity
- Being tested
- Whey protein, Whey protein enriched with calcium, Soy protein, Maltodextrin
- Keywords
- Obesity, Protein intake, Calcium intake, Weight loss, Weight maintenance, Blood lipid profile, Diet induced thermogenesis
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
45g protein/d; Dosage 3x15g protein daily
Whey protein enriched with calciumDietary supplement
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
Soy proteinDietary supplement
45g soy protein/d; dosage 15g soy protein x 3 daily
MaltodextrinDietary supplement
48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
| Study group | Role | What they receive |
|---|---|---|
| Whey protein supplement | Active comparator | Whey protein Receives: Dietary Supplement: Whey protein |
| Whey protein enriched with calcium supplement | Active comparator | Whey protein enriched with calcium Receives: Dietary Supplement: Whey protein enriched with calcium |
| Soy protein supplement | Active comparator | Soy protein Receives: Dietary Supplement: Soy protein |
| Control supplement | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in body weight and composition during the weight maintenance period
Measured: 24 weeks
Secondary outcomes (14)
Difference in fasting blood lipid profile during the weight maintenance period.
Measured: 24 weeks
Difference in fasting insulin, glucose, C-peptide, glucagon, insulin-like growth factor 1 (IGF-1), ionized calcium, parathyroideahormone (PTH), and angiopoietin-like protein 4 (Angpt14) during the weight maintenance period.
Measured: 24 weeks
Difference in resting blood pressure and pulse during the weight maintenance period.
Measured: 24 weeks
Difference in intestinal flora during the weight maintenance period.
Measured: 24 weeks
Nutrigenomics (NMR) analysis.
Measured: 24 weeks
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Measured: 24 weeks
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Measured: 24 weeks.
Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)
Measured: 24 weeks
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Measured: 24 weeks
Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period.
Measured: 24 weeks
Change in body weight and composition during the weight loss period
Measured: 8 weeks
Change in blood lipid profile during the weight loss period
Measured: 8 weeks
Change in fasting insulin, glucose ect. during the weight loss period
Measured: 8 weeks
Change in intestinal flora during the weight loss period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prevention of ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, Nupo A/S, Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Prof., MD, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561131
- Sponsor's protocol ID
- B288
- Acronym
- PROKA
- Status last verified
- Feb 2017
- First submitted
- 20 Mar 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Geiker NRW, Veller M, Kjoelbaek L, Jakobsen J, Ritz C, Raben A, Astrup A, Lorenzen JK, Larsen LH, Bugel S. Effect of low energy diet for eight weeks to adults with overweight or obesity on folate, retinol, vitamin B12, D and E status and the degree of inflammation: a post hoc analysis of a randomized intervention trial. Nutr Metab (Lond). 2018 Apr 10;15:24. doi: 10.1186/s12986-018-0263-1. eCollection 2018.
PubMed 29643928Kjolbaek L, Sorensen LB, Sondertoft NB, Rasmussen CK, Lorenzen JK, Serena A, Astrup A, Larsen LH. Protein supplements after weight loss do not improve weight maintenance compared with recommended dietary protein intake despite beneficial effects on appetite sensation and energy expenditure: a randomized, controlled, double-blinded trial. Am J Clin Nutr. 2017 Aug;106(2):684-697. doi: 10.3945/ajcn.115.129528. Epub 2017 Jul 5.
PubMed 28679554
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
- ClinicalTrials.gov ID
- NCT01561131
- Acronym / sponsor ID
- PROKA / B288
- Conditions
- Prevention of Obesity
- Keywords
- Obesity, Protein intake, Calcium intake, Weight loss, Weight maintenance, Blood lipid profile, Diet induced thermogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods, Nupo A/S, Denmark
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Mar 2012 (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.
The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Furthermore, to examine short-term and long-term effect of a high protein intake on appetite regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on weightmaintence, bloodlipid profilen, appetite regulation and DIT.
The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight and composition will be measured and blood samples will be collected. Meal test will be performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces will be collected three times during the study. Subjects will receive dietary counseling (in groups) regularly during the study and body weight will be measured at each visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whey protein supplement | Active comparator | Dietary Supplement: Whey proteinWhey protein |
| Whey protein enriched with calcium supplement | Active comparator | Dietary Supplement: Whey protein enriched with calciumWhey protein enriched with calcium |
| Soy protein supplement | Active comparator | Dietary Supplement: Soy proteinSoy protein |
| Control supplement | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both men and women can be included
- All ethnic groups can be included
- Age: 18≤age≤60
- BMI: 28≤BMI≤40
Key exclusion criteria (24 listed)
- smoking
- use of cholesterol-lowering medications or other medications considered to be of importance for participation in the trial
- use of special diets (eg. Atkins, vegetarian) within 2 months before the start of the project.
- elite athletes or if subjecct is planning to become elite athlete (e.g. Planning major changes in physical activity during the experiment).
- persons during weight loss period, loss of <8% of their initial body weight
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 |
|---|---|---|
| Whey protein45g protein/d; Dosage 3x15g protein daily | Dietary supplement | Whey protein supplement |
| Whey protein enriched with calcium45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily | Dietary supplement | Whey protein enriched with calcium supplement |
| Soy protein45g soy protein/d; dosage 15g soy protein x 3 daily | Dietary supplement | Soy protein supplement |
| Maltodextrin48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily | Dietary supplement | Control supplement |
Primary outcome
Difference in body weight and composition during the weight maintenance period
Time frame: 24 weeks
14 secondary outcomes
Difference in fasting blood lipid profile during the weight maintenance period.
Time frame: 24 weeks
Difference in fasting insulin, glucose, C-peptide, glucagon, insulin-like growth factor 1 (IGF-1), ionized calcium, parathyroideahormone (PTH), and angiopoietin-like protein 4 (Angpt14) during the weight maintenance period.
Time frame: 24 weeks
Difference in resting blood pressure and pulse during the weight maintenance period.
Time frame: 24 weeks
Difference in intestinal flora during the weight maintenance period.
Time frame: 24 weeks
Nutrigenomics (NMR) analysis.
Time frame: 24 weeks
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Time frame: 24 weeks
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Time frame: 24 weeks.
Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)
Time frame: 24 weeks
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Time frame: 24 weeks
Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period.
Time frame: 24 weeks
Change in body weight and composition during the weight loss period
Time frame: 8 weeks
Change in blood lipid profile during the weight loss period
Time frame: 8 weeks
Change in fasting insulin, glucose ect. during the weight loss period
Time frame: 8 weeks
Change in intestinal flora during the weight loss period.
Time frame: 8 weeks
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 7 Feb 2017.
- Derived from this study: PubMed 29643928Geiker NRW, Veller M, Kjoelbaek L, Jakobsen J, Ritz C, Raben A, Astrup A, Lorenzen JK, Larsen LH, Bugel S. Effect of low energy diet for eight weeks to adults with overweight or obesity on folate, retinol, vitamin B12, D and E status and the degree of inflammation: a post hoc analysis of a randomized intervention trial. Nutr Metab (Lond). 2018 Apr 10;15:24. doi: 10.1186/s12986-018-0263-1. eCollection 2018.
- Derived from this study: PubMed 28679554Kjolbaek L, Sorensen LB, Sondertoft NB, Rasmussen CK, Lorenzen JK, Serena A, Astrup A, Larsen LH. Protein supplements after weight loss do not improve weight maintenance compared with recommended dietary protein intake despite beneficial effects on appetite sensation and energy expenditure: a randomized, controlled, double-blinded trial. Am J Clin Nutr. 2017 Aug;106(2):684-697. doi: 10.3945/ajcn.115.129528. Epub 2017 Jul 5.
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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.
Arne Astrup, Prof., MD principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein, Whey protein enriched with calcium and Soy protein in people with Prevention of Obesity, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 24 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 7 Feb 2017. 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 Denmark. 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?
Difference in body weight and composition during the weight maintenance period (time frame: 24 weeks). 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 NCT01561131, which also lists 2 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 7 Feb 2017.