Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans

NCT04439630 | Completed

• 1 other identifier: Protokoll 2018/8-b
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial

Conditions

Glucose Tolerance; Appetite Sensations

Keywords

healthy subjects; diabetes prevention; obesity prevention

Outcome Measures

Primary Outcomes (2)

• postprandial glucose tolerance

  effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.

  0-180 min after start of the meal

• postprandial insulin concentrations

  effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.

  0-180 min

Secondary Outcomes (1)

• subjective appetite variables

  0-180 min

Study Arms (3)

reference

SHAM COMPARATOR

Test product without the active components

Dietary Supplement: Test product without the active components

Nopal fraction 1

EXPERIMENTAL

Fraction one out of two possible

Dietary Supplement: Nopal fractions

Nopal fraction 2

EXPERIMENTAL

Fraction two out of two possible

Dietary Supplement: Nopal fractions

Interventions

Nopal fractions DIETARY_SUPPLEMENT

Nopal flour were divided in two fractions and mixed in two different test breads

Nopal fraction 1; Nopal fraction 2

Test product without the active components DIETARY_SUPPLEMENT

Test product without the active components

reference

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• non-smokers
• diet accordance with the Nordic Nutrition Recommendations
• BMI: 18.5-25 kg/m2

You may not qualify if:

• metabolic disorders
• food allergies
• no probiotics or other food /supplement which may interfere with the study

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

Location

Study Officials

• Anne Nilsson, assoc. prof.

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants knew which test products that were included in the study, but not the consumption order
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: randomised crossover study in healthy young adults with normal BMI

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)