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Completed

NCT Number: NCT03697486

The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1,Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women

Gut hormones, such as PYY and ghrelin, are associated with appetite control and obesity. Protein is thought to be the most satieting nutrient and could affect production of several gut hormones. This study's objective is to find the effect of breakfast with different protein composition on PYY, ghrelin, and ad libitum intake four hours after breakfast.

The research methodology was used a clinical trial with 22 obese women participants. Subjects were given three types of breakfast: low protein consumption (12.4% protein), medium protein (23.5% protein), and high protein (40,6% protein). PYY and ghrelin level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four hours after breakfast and measured after.

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Key information

Conditions

PYY Appetite Body Weight Ghrelin Gut Hormones Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Protein Consumption Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, 10110, Indonesia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 25-30 (obese)
  • with stable body weight within the last 6 months (body weight change less than 4 kg)
  • normal blood glucose level.

Exclusion criteria

  • patients who never had breakfast
  • patients in weight loss program
  • patients consuming lipid-absorption inhibitor or appetite-suppressing drugs
  • patients that have had gastrointestinal tract resection.

Treatment and study plan

diet with different composition

Behavioral

Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.

After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.

Primary outcomes

  1. Ghrelin levels at 0 minute

    Time frame: baseline

    analyzed by ELISA, directly taken after having the breakfast with different protein composition

  2. Ghrelin levels at 15 minute

    Time frame: 15 minutes

    analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

  3. Ghrelin levels at 60 minute

    Time frame: 60 minutes

    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  4. Ghrelin levels at 120 minute

    Time frame: 120 minutes

    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  5. Ghrelin levels at 180 minute

    Time frame: 180 minutes

    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  6. PYY levels at 0 minute

    Time frame: baseline

    analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition

  7. PYY levels at 15 minute

    Time frame: 15 minutes

    analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition

  8. PYY levels at 60 minute

    Time frame: 60 minutes

    analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition

  9. PYY levels at 120 minute

    Time frame: 120 minutes

    analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition

  10. PYY levels at 180 minute

    Time frame: 180 minutes

    analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition

  11. GLP-1 levels at 0 minute

    Time frame: baseline

    analyzed by ELISA, directly taken after having the breakfast with different protein composition

  12. GLP-1 levels at 15 minute

    Time frame: 15 minutes

    analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

  13. GLP-1 levels at 60 minute

    Time frame: 60 minutes

    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  14. GLP-1 levels at 120 minute

    Time frame: 120 minutes

    analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition

  15. GLP-1 levels at 180 minute

    Time frame: 180 minutes

    analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition

  16. Glucose levels at 0 minute

    Time frame: baseline

    analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition

  17. Glucose levels at 15 minute

    Time frame: 15 minutes

    analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition

  18. Glucose levels at 60 minute

    Time frame: 60 minutes

    analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition

  19. Glucose levels at 120 minute

    Time frame: 120 minutes

    analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition

  20. Glucose levels at 180 minute

    Time frame: 180 minutes

    analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition

  21. Ad Libitum intake

    Time frame: 4 hours

    Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition

  22. VAS for hunger at 0 minutes

    Time frame: baseline

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), directly taken after having the breakfast with different protein composition

  23. VAS for hunger at 15 minutes

    Time frame: 15 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with different protein composition

  24. VAS for hunger at 60 minutes

    Time frame: 60 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with different protein composition

  25. VAS for hunger at 120 minutes

    Time frame: 120 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with different protein composition

  26. VAS for hunger at 180 minutes

    Time frame: 180 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with different protein composition

  27. VAS for satiety at 0 minute

    Time frame: baseline

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken directly after having the breakfast with different protein composition

  28. VAS for satiety at 15 minute

    Time frame: 15 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with different protein composition

  29. VAS for satiety at 60 minute

    Time frame: 60 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with different protein composition

  30. VAS for satiety at 120 minute

    Time frame: 120 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with different protein composition

  31. VAS for satiety at 180 minute

    Time frame: 180 minutes

    Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with different protein composition

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital
  • SEAMEO Regional Centre for Food and Nutrition

Registry information

Official study title

The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1, Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2018
Registry last updated
Oct 10, 2018

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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