NCT03305718

Brief Summary

The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 4, 2017

Last Update Submit

October 9, 2017

Conditions

Biomarkers of Food Intake in Healthy Subjects

Outcome Measures

Primary Outcomes (5)

  • Urinary meat metabolites (metabolic profiling with mass spectrometry)

    Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat

    Hours 0-48

  • Plasma meat metabolites (metabolic profiling with mass spectrometry)

    Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat

    Hours 0-48

  • Urinary potato metabolites (metabolic profiling with mass spectrometry)

    Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods

    Hours 0-48

  • Plasma potato metabolites (metabolic profiling with mass spectrometry)

    Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods

    Hours 0-48

  • Objective assessment of satiety

    Measured by the weight of an ad libitum meal

    Hours 0-7

Secondary Outcomes (4)

  • Urine biomarkers of meat intake

    Hours 0-48

  • Subjective assessment of satiety

    Hours 0-6

  • Area under the curve for glucose

    Minutes 0-180

  • Area under the curve for insulin

    Minutes 0-180

Study Arms (12)

Meal sequence: 3C1A2B4D

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D.

Other: Meal sequence: 3C1A2B4D

Meal sequence: 2A3D4C1B

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B.

Other: Meal sequence: 2A3D4C1B

Meal sequence: 2D4B3A1C

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C.

Other: Meal sequence: 2D4B3A1C

Meal sequence: 3B2C1D4A

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A.

Other: Meal sequence: 3B2C1D4A

Meal sequence: 4C2B1A3D

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D.

Other: Meal sequence: 4C2B1A3D

Meal sequence:1B4D3C2A

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A.

Other: Meal sequence:1B4D3C2A

Meal sequence:4A1C2D3B

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B.

Other: Meal sequence:4A1C2D3B

Meal sequence:1D3A4B2C

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C.

Other: Meal sequence:1D3A4B2C

Meal sequence: 4D3B2C1A

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A.

Other: Meal sequence: 4D3B2C1A

Meal sequence: 3A4C1B2D

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D.

Other: Meal sequence: 3A4C1B2D

Meal sequence: 1C2A3D4B

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B.

Other: Meal sequence: 1C2A3D4B

Meal sequence: 2B1D4A3C

EXPERIMENTAL

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C.

Other: Meal sequence: 2B1D4A3C

Interventions

Meal sequence: 3C1A2B4DOTHER

Participants receive test meals in the sequence 3C1A2B4D

Meal sequence: 3C1A2B4D
Meal sequence: 2A3D4C1BOTHER

Participants receive test meals in the sequence 2A3D4C1B

Meal sequence: 2A3D4C1B
Meal sequence: 2D4B3A1COTHER

Participants receive test meals in the sequence 2D4B3A1C

Meal sequence: 2D4B3A1C
Meal sequence: 3B2C1D4AOTHER

Participants receive test meals in the sequence 3B2C1D4A

Meal sequence: 3B2C1D4A
Meal sequence: 4C2B1A3DOTHER

Participants receive test meals in the sequence 4C2B1A3D

Meal sequence: 4C2B1A3D
Meal sequence:1B4D3C2AOTHER

Participants receive test meals in the sequence 1B4D3C2A

Meal sequence:1B4D3C2A
Meal sequence:4A1C2D3BOTHER

Participants receive test meals in the sequence 4A1C2D3B

Meal sequence:4A1C2D3B
Meal sequence:1D3A4B2COTHER

Participants receive test meals in the sequence 1D3A4B2C

Meal sequence:1D3A4B2C
Meal sequence: 4D3B2C1AOTHER

Participants receive test meals in the sequence 4D3B2C1A

Meal sequence: 4D3B2C1A
Meal sequence: 3A4C1B2DOTHER

Participants receive test meals in the sequence 3A4C1B2D

Meal sequence: 3A4C1B2D
Meal sequence: 1C2A3D4BOTHER

Participants receive test meals in the sequence 1C2A3D4B

Meal sequence: 1C2A3D4B
Meal sequence: 2B1D4A3COTHER

Participants receive test meals in the sequence 2B1D4A3C

Meal sequence: 2B1D4A3C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \< 30 kg/m2
  • Eating and tolerating meat, egg, pea, rice, and potatoes
  • No current chronic or infectious disease
  • No medication (oral contraceptive pill and mild antidepressants is allowed)
  • No dietary supplements
  • Did not use antibiotics in the 6 previous months

You may not qualify if:

  • Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
  • Pregnant or lactating women
  • Smoking (12 months of non-smoking is allowed)
  • Vegan or vegetarian
  • Have or have had a drug addiction
  • Blood donations within three months before participating in the current trial or participation in other scientific experiments
  • Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14 drinks/week for women and men, respectively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 10, 2017

Study Start

February 15, 2015

Primary Completion

May 30, 2015

Study Completion

May 30, 2015

Last Updated

October 10, 2017

Record last verified: 2017-10