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The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile (PROKA)

Primary Purpose

Prevention of Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey protein
Whey protein enriched with calcium
Soy protein
Maltodextrin
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Obesity focused on measuring Obesity, Protein intake, Calcium intake, Weight loss, Weight maintenance, Blood lipid profile, Diet induced thermogenesis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both men and women can be included
  • All ethnic groups can be included
  • Age: 18≤age≤60
  • BMI: 28≤BMI≤40

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • Department of Human Nutrition, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Whey protein supplement

Whey protein enriched with calcium supplement

Soy protein supplement

Control supplement

Arm Description

Whey protein

Whey protein enriched with calcium

Soy protein

Maltodextrin

Outcomes

Primary Outcome Measures

Difference in body weight and composition during the weight maintenance period

Secondary Outcome Measures

Difference in fasting blood lipid profile during the weight maintenance period.
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.
Difference in resting blood pressure and pulse during the weight maintenance period.
Difference in intestinal flora during the weight maintenance period.
Nutrigenomics (NMR) analysis.
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period.
Change in body weight and composition during the weight loss period
Change in blood lipid profile during the weight loss period
Change in fasting insulin, glucose ect. during the weight loss period
Change in intestinal flora during the weight loss period.

Full Information

First Posted
March 20, 2012
Last Updated
February 6, 2017
Sponsor
University of Copenhagen
Collaborators
Arla Foods, Nupo A/S, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01561131
Brief Title
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Acronym
PROKA
Official Title
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Arla Foods, Nupo A/S, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Obesity
Keywords
Obesity, Protein intake, Calcium intake, Weight loss, Weight maintenance, Blood lipid profile, Diet induced thermogenesis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein supplement
Arm Type
Active Comparator
Arm Description
Whey protein
Arm Title
Whey protein enriched with calcium supplement
Arm Type
Active Comparator
Arm Description
Whey protein enriched with calcium
Arm Title
Soy protein supplement
Arm Type
Active Comparator
Arm Description
Soy protein
Arm Title
Control supplement
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
45g protein/d; Dosage 3x15g protein daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein enriched with calcium
Intervention Description
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein
Intervention Description
45g soy protein/d; dosage 15g soy protein x 3 daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
Primary Outcome Measure Information:
Title
Difference in body weight and composition during the weight maintenance period
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Difference in fasting blood lipid profile during the weight maintenance period.
Time Frame
24 weeks
Title
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
Title
Difference in resting blood pressure and pulse during the weight maintenance period.
Time Frame
24 weeks
Title
Difference in intestinal flora during the weight maintenance period.
Time Frame
24 weeks
Title
Nutrigenomics (NMR) analysis.
Time Frame
24 weeks
Title
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Time Frame
24 weeks
Title
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Time Frame
24 weeks.
Title
Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)
Time Frame
24 weeks
Title
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Time Frame
24 weeks
Title
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
Title
Change in body weight and composition during the weight loss period
Time Frame
8 weeks
Title
Change in blood lipid profile during the weight loss period
Time Frame
8 weeks
Title
Change in fasting insulin, glucose ect. during the weight loss period
Time Frame
8 weeks
Title
Change in intestinal flora during the weight loss period.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both men and women can be included All ethnic groups can be included Age: 18≤age≤60 BMI: 28≤BMI≤40 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Prof., MD
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, University of Copenhagen
City
Frederiksberg, Copenhagen
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29643928
Citation
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.
Results Reference
derived
PubMed Identifier
28679554
Citation
Kjolbaek 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.
Results Reference
derived

Learn more about this trial

The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile

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