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

NCT ID: NCT01561131

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Prevention of Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Whey protein supplement

Whey protein

Group Type: ACTIVE_COMPARATOR

Whey protein

Intervention Type: DIETARY_SUPPLEMENT

45g protein/d; Dosage 3x15g protein daily

Whey protein enriched with calcium supplement

Whey protein enriched with calcium

Group Type: ACTIVE_COMPARATOR

Whey protein enriched with calcium

Intervention Type: DIETARY_SUPPLEMENT

45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily

Soy protein supplement

Soy protein

Group Type: ACTIVE_COMPARATOR

Soy protein

Intervention Type: DIETARY_SUPPLEMENT

45g soy protein/d; dosage 15g soy protein x 3 daily

Control supplement

Maltodextrin

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

Interventions

Whey protein

45g protein/d; Dosage 3x15g protein daily

Intervention Type: DIETARY_SUPPLEMENT

Whey protein enriched with calcium

45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily

Intervention Type: DIETARY_SUPPLEMENT

Soy protein

45g soy protein/d; dosage 15g soy protein x 3 daily

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arla Foods

INDUSTRY

Sponsor Role: collaborator

Nupo A/S, Denmark

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Arne Astrup

Prof., MD, Head of Department, Department of Human Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arne Astrup, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, University of Copenhagen

Locations

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29643928 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28679554 (View on PubMed)

Other Identifiers

B288

Identifier Type: -

Identifier Source: org_study_id