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

NCT01561131 | Completed

• 1 other identifier: B288
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Protein intake; Calcium intake; Weight loss; Weight maintenance; Blood lipid profile; Diet induced thermogenesis

Outcome Measures

Primary Outcomes (1)

• Difference in body weight and composition during the weight maintenance period

  24 weeks

Secondary Outcomes (14)

• Difference in fasting blood lipid profile during the weight maintenance period.

  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.

  24 weeks

• Difference in resting blood pressure and pulse during the weight maintenance period.

  24 weeks

• Difference in intestinal flora during the weight maintenance period.

  24 weeks

• Nutrigenomics (NMR) analysis.

  24 weeks

Study Arms (4)

Whey protein supplement

ACTIVE COMPARATOR

Whey protein

Dietary Supplement: Whey protein

Whey protein enriched with calcium supplement

ACTIVE COMPARATOR

Whey protein enriched with calcium

Dietary Supplement: Whey protein enriched with calcium

Soy protein supplement

ACTIVE COMPARATOR

Soy protein

Dietary Supplement: Soy protein

Control supplement

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

Whey protein DIETARY_SUPPLEMENT

45g protein/d; Dosage 3x15g protein daily

Whey protein supplement

Whey protein enriched with calcium DIETARY_SUPPLEMENT

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

Whey protein enriched with calcium supplement

Soy protein DIETARY_SUPPLEMENT

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

Soy protein supplement

Maltodextrin DIETARY_SUPPLEMENT

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

Control supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Arla Foods: collaborator
• Nupo A/S, Denmark: collaborator

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29643928 DERIVED

• 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.

  PMID: 28679554 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Whey Proteins; Calcium; Soybean Proteins; maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Plant Proteins; Plant Proteins, Dietary; Soy Foods; Vegetable Products; Vegetables

Study Officials

• Arne Astrup, Prof., MD

  Department of Human Nutrition, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, Head of Department, Department of Human Nutrition

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

DK (1)