Whole Milk Compared With Skimmed Milk and Effect on Lipids

NCT03052582 | Completed

• 1 other identifier: M227
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on:

• Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides
• Risk markers of diabetes type 2: plasma glucose and insulin

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Fasting blood lipids

  total, LDL and HDL cholesterol and TAG

  3 weeks

Secondary Outcomes (2)

• fasting plasma glucose

  3 weeks

• fasting serum insulin

  3 weeks

Study Arms (2)

Team 1: skimmed/whole

ACTIVE COMPARATOR

Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk

Other: Milk type

Team 2: whole/skimmed

ACTIVE COMPARATOR

Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk

Other: Milk type

Interventions

Milk type OTHER

Team 1: skimmed/whole; Team 2: whole/skimmed

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must give their informed consent in writing, after having received oral and written information about the study
• Age: 20-70 y
• BMI: 18.5 - 30 kg/m2
• Healthy men and women (with no known diseases)

You may not qualify if:

• Current or previous cardiovascular disease, high blood pressure or cholesterol
• Diabetes Mellitus or other severe chronic disease, including severe allergies
• Lactose intolerant or milk allergy
• Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention
• Known or suspected abuse of alcohol, drugs or medication
• Pregnant or are planning pregnancy during the study period
• Extreme physical activity level (more than 10 hours tough physical activity pr. week)
• Participation in other research studies
• Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, 1958, Denmark

Location

Related Publications (2)

• Hansen NM, Berg P, Rix M, Pareek M, Leipziger J, Kamper AL, Astrup A, Vaarby Sorensen M, Salomo L. The New Nordic Renal Diet Induces a Pronounced Reduction of Urine Acid Excretion and Uremic Toxins in Chronic Kidney Disease Patients (Stage 3 and 4). J Ren Nutr. 2023 May;33(3):412-419. doi: 10.1053/j.jrn.2022.09.010. Epub 2022 Oct 3.

  PMID: 36195272 DERIVED

• Engel S, Elhauge M, Tholstrup T. Effect of whole milk compared with skimmed milk on fasting blood lipids in healthy adults: a 3-week randomized crossover study. Eur J Clin Nutr. 2018 Feb;72(2):249-254. doi: 10.1038/s41430-017-0042-5. Epub 2017 Dec 11.

  PMID: 29229955 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tine Tholstrup, Ass Prof.

  Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 14, 2017
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

DK (1)