NCT02616471

Brief Summary

The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors. It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons). In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

January 20, 2014

Last Update Submit

August 28, 2018

Conditions

Metabolic Syndrome

Keywords

CheeseDairySaturated fatBlood lipid concentrationsLipoprotein particle sizeMetabolic SyndromeInsulin sensitivityBlood glucose concentrations

Outcome Measures

Primary Outcomes (1)

  • Changes in LDL cholesterol from baseline to post-intervention

    fasting, mmol/l

    week 1 and week 12

Secondary Outcomes (9)

  • Blood lipid concentrations

    week 1 and week 12

  • Particle size

    week 1 and week 12

  • Anthropometry

    5 times during the 12-week intervention

  • Blood pressure (BP)

    3 time during the 12-week intervention

  • Insulin sensitivity

    week 1 and week 12

  • +4 more secondary outcomes

Study Arms (3)

High-fat cheese (HFC) group

EXPERIMENTAL

The subjects in the HFC group will be supplied with equal amounts of two types of regular/high fat cheeses. The cheeses are normal-fat Danbo (Riberhus, 25% fat, Arla, DK) and normal-fat Cheddar (Sharp Cheddar, 32% fat, Cabot, US). No further dairy and cheese consumption is allowed

Dietary Supplement: High-fat cheese

Low-fat cheese (LFC) group

EXPERIMENTAL

The subjects in the LFC group will be supplied with equal amounts of two types of reduced/low fat cheeses. The cheeses are reduced-fat Danbo(Cheasy, 13% fat, Arla, DK) and reduced-fat Cheddar (Sharp Light Cheddar, 16% fat, Cabot, US). No further dairy/cheese consumption is allowed.

Dietary Supplement: Low-fat cheese

No-cheese/carbohydrate group (CTR)

ACTIVE COMPARATOR

For subjects in the CTR group, cheese is replaced by simple and starchy carbohydrates in jam and white bread, which will be supplied by the department. The daily energy and sodium contents will be matched to those of the cheese in the HFC group. No dairy/cheese consumption is allowed.

Dietary Supplement: No-cheese/carbohydrate

Interventions

High-fat cheeseDIETARY_SUPPLEMENT
High-fat cheese (HFC) group
Low-fat cheeseDIETARY_SUPPLEMENT
Low-fat cheese (LFC) group
No-cheese/carbohydrateDIETARY_SUPPLEMENT
No-cheese/carbohydrate group (CTR)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women
  • Age 18-70
  • Waist circumference \> 80 cm for women / \> 94 cm for men
  • Plus at least one additional established risk factor for the metabolic syndrome using the following criteria:
  • Elevated BP (Systolic BP \> 130 mmHg and/or diastolic BP \> 85 mmHg);
  • Elevated triglycerides (\>1.7 mmol/l);
  • Reduced HDL-C (\<1.0 mmol/l for men and \< 1.3 mmol/l for women);
  • Elevated fasting glucose (\> 5.6 mmol/l). BMI 18.5 - 35 kg/m2

You may not qualify if:

  • Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study)
  • Milk allergy
  • Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
  • \>10 hours of strenuous physical activity per week
  • Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety)
  • Drug or alcohol abuse
  • Blood donation \<1 month before study commencement and during study period
  • Simultaneous participation in other clinical studies
  • Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months.
  • Inability to comply with the procedures required by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sport

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

  • Raziani F, Tholstrup T, Kristensen MD, Svanegaard ML, Ritz C, Astrup A, Raben A. High intake of regular-fat cheese compared with reduced-fat cheese does not affect LDL cholesterol or risk markers of the metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2016 Oct;104(4):973-981. doi: 10.3945/ajcn.116.134932. Epub 2016 Aug 24.

    PMID: 27557654DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Arne Astrup, Prof, MD

    Head of Department of Nutrition, Exercise and Sports

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports

Study Record Dates

First Submitted

January 20, 2014

First Posted

November 30, 2015

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

DK(1)