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The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite

Early Phase 1
Completed
Conditions
Insulin Sensitivity
Glucose Intolerance
Interventions
Other: Meal sequence 1-3-2
Other: Meal sequence 3-2-1
Other: Meal sequence 1-2-3
Other: Meal sequence 3-1-2
Other: Meal sequence 2-3-1
Other: Meal sequence 2-1-3
Registration Number
NCT02412995
Lead Sponsor
University of Copenhagen
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Meal sequence 1-3-2Meal sequence 1-3-2The 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
Meal sequence 3-2-1Meal sequence 3-2-1The 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
Meal sequence 1-2-3Meal sequence 1-2-3The 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
Meal sequence 3-1-2Meal sequence 3-1-2The 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
Meal sequence 2-3-1Meal sequence 2-3-1The 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
Meal sequence 2-1-3Meal sequence 2-1-3The 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
Primary Outcome Measures
NameTimeMethod
Glycemia Area under the plasma glucose concentration curve, concentration curve.postprandially 0-120min

Area under the plasma glucose concentration curve, concentration curve.

Secondary Outcome Measures
NameTimeMethod
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)0-120 min

Gycemic 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)

Incremental insulin response Incremental area under the plasma insulin concentration curve.Postprandially 0-30 and 0-60 min

Incremental area under the plasma insulin concentration curve.

urine metabolic profile0-24 hrs

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 (UPLC-QTOF)

plasma metabolic profile (metabolic profiling by UPLC-QTOF)0-120min

Blood samples were drawn at t = -20 (baseline), 30, 45, 60, 90 and 120 min on each test day and subjected to untargeted metabolic profiling by UPLC-QTOF

Insulin response Area under the plasma insulin concentration curvepostprandially 0-120min

Area under the plasma insulin concentration curve

Appetite scores (visual analogue scale)postprandially 0-140min

Measured on a 100 mm visual analogue scale spanning the sensation from minimum to maximum on the following: hunger, satiety, fullness, perceived prospective food intake, thirst, well-being, and desire for something sweet.

Incremental area under the plasma glucose concentration curvepostprandially, 0-30 and 0-60min

The area under the initial part of the glucose plasma curve from the volunteer has ingested the sugar solution until 60 min later

Meal perception VAS questionnairepostprandially at 30min and 140 min

A VAS questionnaire concerning meal perception with ratings for taste (poor/good), smell (not appetising/appetising), appearance (not appetising/appetising), undertaste (none/much), and overall impression (not appetising/appetising).

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

🇩🇰

Frederiksberg C, Denmark

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