Whey Protein Micelles and Thermogenesis in Overweight Subjects

NCT02303080 | Completed

• 1 other identifier: 10.19.MET
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels. It will be a randomized crossover double-blind design conducted in 20 subjects.

Conditions

Overweight

Keywords

whey protein microgels; thermogenesis

Outcome Measures

Primary Outcomes (1)

• thermic effect of food

  gas exchanges through indirect calorimetry

  7 hours from baseline measurements

Secondary Outcomes (1)

• Whole body protein turnover

  7 hours from baseline

Study Arms (4)

Control (WPM 0)

PLACEBO COMPARATOR

400 mL beverage with 85.0% maltodextrine, 15.0% fat and 0% of whey protein micelles Product given once after 1 hour of monitoring for baseline

Other: WPM 30; Other: WPM 50; Other: MC 50

WPM 30

ACTIVE COMPARATOR

400 mL beverage with 43.7% of maltodextrine, 15.2 % fat and 41.1% (30 g) of whey protein micelles Product given once after 1 hour of monitoring for baseline

Other: Control (WPM 0); Other: WPM 50; Other: MC 50

WPM 50

ACTIVE COMPARATOR

400 mL beverage with 16.3% of maltodextrine, 15.2 % fat and 68.5% (50 g) of whey protein micelles Product given once after 1 hour of monitoring for baseline

Other: Control (WPM 0); Other: WPM 30; Other: MC 50

MC 50

ACTIVE COMPARATOR

400 mL beverage with 16.7% of maltodextrine, 15.0 % fat and 68.2% (50 g) of whey protein micelles 50 g of micellar casein Product given once after 1 hour of monitoring for baseline

Other: Control (WPM 0); Other: WPM 30; Other: WPM 50

Interventions

Control (WPM 0) OTHER

85.0 % maltodextrin,15.0% fat, 0% WPM

MC 50; WPM 30; WPM 50

WPM 30 OTHER

43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM

Control (WPM 0); MC 50; WPM 50

WPM 50 OTHER

16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM

Control (WPM 0); MC 50; WPM 30

MC 50 OTHER

16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC

Control (WPM 0); WPM 30; WPM 50

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her subjects over 20 year informed consent.

You may not qualify if:

• Chronic or acute diseases affecting protein metabolism (diabetes, renal insufficiency, CVD, liver disease), dyslipidemia History of varicose or venous stases Recent major surgery (3 months) History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc…) Malabsorption disorders History of cancer within the past year Significant weight loss during the last 3 months Food allergies, especially cow milk protein. Pregnancy or lactation Special diets especially vegetarian, high protein (≥ 1.6 g/kg) or weight loss program Abnormal Food Frequency Questionnaire Aversion to vanilla or chocolate aromas Smoking Moderate to intense physical activity \> 2 hours/week Hematocrit \<40 for males and \< 36 for females Blood donation within 3 months of study start and 3 months after study end Regular consumption of medication and supplements i.e. any treatment affecting thermogenesis or nutrient metabolism in general such as corticosteroids, insulin, androgens, antibiotics and nutritional supplements (multivitamins, protein shakes).
• Have a high alcohol consumption (more than 1 drink/day) Consumption of illicit drugs Subject who cannot be expected to comply with the study procedures, including consuming the test products.
• Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Related Publications (1)

• Kassis A, Godin JP, Moille SE, Nielsen-Moennoz C, Groulx K, Oguey-Araymon S, Praplan F, Beaumont M, Sauser J, Monnard I, Kapp AF, Ammon-Zufferey C, Frei N, Guignard L, Delodder F, Mace K. Effects of protein quantity and type on diet induced thermogenesis in overweight adults: A randomized controlled trial. Clin Nutr. 2019 Aug;38(4):1570-1580. doi: 10.1016/j.clnu.2018.08.004. Epub 2018 Aug 10.

  PMID: 30269898 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Maurice Beaumont, MD, PhD

  Société des Produits Nestlé (SPN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 27, 2014
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 14, 2025

Record last verified: 2014-11