NCT05069506

Brief Summary

This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective appetite and energy intake in healthy, normal weight adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

April 6, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

July 9, 2019

Last Update Submit

September 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Capillary blood glucose

    Clinically useful change in serum glucose (mg/dL), defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test and for a total of 5 hours

    7 hours

Secondary Outcomes (3)

  • Subjective appetite ratings

    7 hours

  • Energy intake after preload

    6 hours

  • Arterial blood pressure

    7 hours

Study Arms (7)

Glucose as reference food

EXPERIMENTAL

Twelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Goat milk as test food

EXPERIMENTAL

Twelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Goat milk and currants as test food

EXPERIMENTAL

Twelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Currants as test food

EXPERIMENTAL

Twelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Sultanina raisins as test food

EXPERIMENTAL

Twelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Goat milk as preload

EXPERIMENTAL

Forty-five healthy subjects (male: 12, female: 33) were offered a standardized breakfast and 2h after consumed one of the two preloads (goat milk yogurt and milk with lactic acid) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Milk with lactic acid as preload

EXPERIMENTAL

Forty-five healthy subjects (male: 12, female: 33) were offered a standardized breakfast and 2h after consumed one of the two preloads (goat milk yogurt and milk with lactic acid) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).

Other: Glucose as reference foodOther: Goat milk as test foodOther: Goat milk and currants as test foodOther: Currants as test foodOther: Sultanina raisins as test foodOther: Goat milk yogurt as preloadOther: Milk with lactic acid as preload

Interventions

Twelve subjects (male: 4 female: 8) consumed 25g glucose diluted in 150ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Twelve subjects (male: 4 female: 8) consumed 617 g goat milk yogurt, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Twelve subjects (male: 4 female: 8) consumed 308 g goat milk yogurt and 19 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Twelve subjects (male: 4 female: 8) consumed 37.8 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Twelve subjects (male: 4 female: 8) consumed 37.5 g sultanina raisins, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g goat milk yogurt). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g milk with lactic acid). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.

Currants as test foodGlucose as reference foodGoat milk and currants as test foodGoat milk as preloadGoat milk as test foodMilk with lactic acid as preloadSultanina raisins as test food

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

You may not qualify if:

  • Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions)
  • Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)
  • Lactose intolerance
  • Pregnancy
  • Competitive sports
  • Lactation
  • Alcohol
  • Drug dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agricultural University of Athens

Athens, 11855, Greece

Location

MeSH Terms

Interventions

GlucoseMilkLactic Acid

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesLactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Investigator)
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Other: Glucose as reference food Other: goat milk yogurt as test food Other: goat milk yogurt with currants as test food Other: currants as test food Other: sultanina raisins as test food Other: goat milk preload Other: milk with lactic acid preload
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Nutrition and Metabolism

Study Record Dates

First Submitted

July 9, 2019

First Posted

October 6, 2021

Study Start

April 6, 2019

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations