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Completed

NCT Number: NCT02770833

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.

The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety. The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.

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Key information

Conditions

Overweight Behavior Body Weight Feeding Behavior Food Preferences Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women
  • Between 18 and 50 years of age
  • BMI between 25.0 and 30.0 kg×m-2
  • Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit)
  • Non-smoker

Exclusion criteria

  • Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
  • Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
  • Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
  • Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
  • Menopausal women and women with an irregular menstrual cycle
  • Food allergies
  • Substance abuse
  • Vigorous physical activity more than 10 hours/week
  • Alcohol intake above the recommendations from the Danish Health and Medicines Authority
  • Caffeine intake above 300 mg/day
  • Night- or shift work
  • Blood donation <1 month before study commencement and during study period
  • Simultaneous participation in other clinical studies
  • Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
  • Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert

Treatment and study plan

Fish and carbohydrats with low or high GI

Other

Veal and carbohydrats with low or high GI

Other

Primary outcomes

  1. Differences in diet induced thermogenesis between the four test meals

    Time frame: 3 hours

    In the following three hours after eating the test meal respiratory gas exchange will be measured 6x25 minutes with 5 minutes breaks in between each measurement. Diet induced thermogenesis (DIT) will be measured by indirect calorimetry using a ventilated hood system. Each measurement will last for 25 minutes of which the last 20 minutes will be used for calculation of energy expenditure.

Secondary outcomes

  1. Satiety

    Time frame: 3 hours

    Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)

  2. Food preferences

    Time frame: 3 hours

    In an attempt to measure spontaneous energy intake and macronutrient preferences in an experimental context, the participants will be given an ad libitum buffet lunch at noon. A cold and hot buffet-style lunch comprising a variety of foods (representing a wide selection of food groups) will be offered after the last measurement of gas exchange and the participants will be instructed to eat ad libitum.

  3. Glucose

    Time frame: 3 hours

    Blood sample

  4. Insulin

    Time frame: 3 hours

    Blood sample

  5. Glucagon

    Time frame: 3 hours

    Blood sample

  6. C-peptide

    Time frame: 3 hours

    Blood sample

  7. Plasma amino acids

    Time frame: 3 hours

    Blood samples

  8. Appetite regulating hormones

    Time frame: 3 hours

    e.g. glucagon-like peptide-1 (GLP-1)

  9. Free fatty acids

    Time frame: 3 hours

    Blood sample

  10. Glycerol

    Time frame: 3 hours

    Blood sample

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • National Institute of Nutrition and Seafood Research, Norway
  • The Fisheries and Aquaculture Industry Research Fund

Registry information

Official study title

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.

Acronym: FINS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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