NCT02412995

Brief Summary

The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

February 8, 2015

Last Update Submit

April 8, 2015

Conditions

Insulin SensitivityGlucose Intolerance

Keywords

sea buckthornstrawberryglucose responsesatietymetabolomicsintake biomarker

Outcome Measures

Primary Outcomes (1)

  • Glycemia Area under the plasma glucose concentration curve, concentration curve.

    Area under the plasma glucose concentration curve, concentration curve.

    postprandially 0-120min

Secondary Outcomes (8)

  • Insulin response Area under the plasma insulin concentration curve

    postprandially 0-120min

  • Appetite scores (visual analogue scale)

    postprandially 0-140min

  • urine metabolic profile

    0-24 hrs

  • plasma metabolic profile (metabolic profiling by UPLC-QTOF)

    0-120min

  • Meal perception VAS questionnaire

    postprandially at 30min and 140 min

  • +3 more secondary outcomes

Study Arms (6)

Meal sequence 1-2-3

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-2-3

Other: Meal sequence 1-2-3

Meal sequence 1-3-2

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-3-2

Other: Meal sequence 1-3-2

Meal sequence 2-3-1

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-3-1

Other: Meal sequence 2-3-1

Meal sequence 2-1-3

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-1-3

Other: Meal sequence 2-1-3

Meal sequence 3-1-2

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-1-2

Other: Meal sequence 3-1-2

Meal sequence 3-2-1

EXPERIMENTAL

The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-2-1

Other: Meal sequence 3-2-1

Interventions

Meal sequence 1-2-3OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 1-2-3
Meal sequence 1-3-2OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 1-3-2
Meal sequence 2-3-1OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 2-3-1
Meal sequence 2-1-3OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 2-1-3
Meal sequence 3-1-2OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 3-1-2
Meal sequence 3-2-1OTHER

The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.

Meal sequence 3-2-1

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2

You may not qualify if:

  • Any current or chronic clinical conditions
  • Chronic/frequent use of medication
  • Smoking
  • Blood donation
  • High level of strenuous physical activity (\>10h/week)
  • High habitual alcohol consumption (\>14 drinks/week)
  • Present or previous drug abuse
  • Participation in other human intervention studies, and obesity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Insulin ResistanceGlucose Intolerance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Study Officials

  • Lars O Dragsted, Ph.D.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2015

First Posted

April 9, 2015

Study Start

October 1, 2012

Primary Completion

November 1, 2012

Study Completion

February 1, 2015

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

DK(1)