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Completed

NCT Number: NCT05061485

The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion

The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.

Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed consent
  • Caucasian
  • Healthy men and women
  • Age between 18-50 years
  • Body mass index (BMI) between 20-27 kg/m2

Exclusion criteria

  • Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
  • Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the principal investigator/clinical responsible)
  • Blood donation within the last 3 months or during the study period
  • Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
  • Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
  • Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
  • Food allergies or food intolerance relevant for the study
  • Substance abuse (within the last 12 months)
  • Alcohol intake above the recommendations from the Danish Health and Medicines Authority
  • Simultaneous participation in other clinical studies that can interfere with the current study
  • Inability, physically or mentally, to comply with the procedures required by the study protocol

Treatment and study plan

Sucrose

Other

The participants consume A) water with 75 g sucrose

Sucrose + protein

Other

The participants consume B) water with 75 g sucrose + approx. 100 kcal protein

Sucrose + fat

Other

The participants C) water with 75 g sucrose + approx. 100 kcal fat

Primary outcomes

  1. Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein

    Time frame: Difference in plasma concentration of FGF21 between two test days

    Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+protein. Concentration of FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

Secondary outcomes

  1. Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat

    Time frame: Difference in plasma concentration of FGF21 between two test days

    Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+fat. FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  2. Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in plasma concentration of glucose between the three test days

    Difference (mmol/l) in plasma glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Glucose is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  3. Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in serum concentration of insulin between the three test days

    Difference (pmol/l) in serum insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Insulin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  4. Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in plasma concentration of glucagon between the three test days

    Difference (pg/ml) in plasma glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Glucagon is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  5. Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in serum concentration of triglycerides between the three test days

    Difference (mmol/l) in serum triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Triglyceride is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  6. Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in serum concentration of amino acids between the three test days

    Difference in serum amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Amino acids are measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  7. Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in plasma glicentin between the three test days

    Difference (pmol/l) in plasma glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. Glicentin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  8. Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in plasma CCK between the three test days

    Difference (pmol/l) in plasma CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat. CCK is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.

  9. Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.

    Time frame: Difference in appetite for sweet between the three test days

    Difference in appetite for sweet is measured using visual analog scales (VAS). The VAS consists of a 100 mm horizontal unbroken line with words anchored at each end describing the extremes. The participants respond to the question asked by placing a vertical mark through the horizontal line corresponding to their perceived feeling at that particular time. Appetite for sweet is assessed at time 0 and 30, 60, 120, 180, and 240 min after consuming the test drinks.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2021
Registry last updated
Mar 31, 2022

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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