Clinical trial NCT02412995: The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite
Official title: The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite - A Randomised, Controlled, Crossover Study of Danish Berries in Overweight and Obese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Insulin Sensitivity
Glucose Intolerance
Keywords: sea buckthorn
strawberry
glucose response
satiety
metabolomics
intake biomarker
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Nordea-fonden
First posted: 2015-04-09
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Purpose: Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.

Methods: 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 t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glycemia Area under the plasma glucose concentration curve, concentration curve.
timeFrame: postprandially 0-120min
Secondary outcomes:
measure: Insulin response Area under the plasma insulin concentration curve
timeFrame: postprandially 0-120min
measure: Appetite scores (visual analogue scale)
timeFrame: postprandially 0-140min
measure: urine metabolic profile
timeFrame: 0-24 hrs
measure: plasma metabolic profile (metabolic profiling by UPLC-QTOF)
timeFrame: 0-120min
measure: Meal perception VAS questionnaire
timeFrame: postprandially at 30min and 140 min
measure: Incremental area under the plasma glucose concentration curve
timeFrame: postprandially, 0-30 and 0-60min
measure: Glycemic profile (calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)
timeFrame: 0-120 min
measure: Incremental insulin response Incremental area under the plasma insulin concentration curve.
timeFrame: Postprandially 0-30 and 0-60 min
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Lars O Dragsted, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: