Effect of Baobab Fruit on Postprandial Glycaemia in Healthy Adults

NCT05140629 | Completed

• 1 other identifier: 518baobab
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Baobab fruits have been traditionally used in Africa due to its therapeutic proprieties attributed to it high polyphenol content. The aim of the study was to investigate the effect of baobab fruit on postprandial glycaemia on healthy adults and to measure its bioactive compounds and antioxidant activity. The study was conducted on 31 healthy subjects. The participants were randomly allocated in control group (oral glucose tolerance test (OGTT); n = 16) and in intervention group (OGTT followed by administration of 250 ml baobab aqueous extract (BAE); n = 15). Total phenols, proanthocyanidins, hydrolysable tannins and antioxidant activity (FRAP, DPPH, ABTS and inhibition of O2•- and NO• methods) were quantified. Repeated Measures ANOVA of mixed type and Independent samples t-test were used.

Conditions

Hyperglycemia, Postprandial

Keywords

Adansonia digitata; Baobab fruit; Postprandial glycaemia; Antioxidant; Polyphenols; Proanthocyanidins

Outcome Measures

Primary Outcomes (3)

• Postprandial blood glucose levels time curve

  Mean blood glucose levels (mmol/L) obtained after oral glucose tolerance test in control group and after oral glucose tolerance test plus baobab extract in intervention group at different moments

  Before intervention and after 30, 60, 90, and 120 minutes after intervention

• Incremental area under the curve of glucose levels

  the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0).

  At 120 minutes after intervention

• Blood glucose maximum concentrations

  Mean blood glucose levels (mmol/L)

  At 120 minutes after intervention

Secondary Outcomes (15)

• Weight of participants

  At baseline

• Body mass index of participants

  At baseline

• Height of participants

  At baseline

• Total energy intake intake of participants

  At the day before intervention

• Total protein intake of participants

  At the day before intervention

Study Arms (2)

Placebo (OGTT)

PLACEBO COMPARATOR

The control group participants ingested glucose solution alone (OGTT) prepared with 75 g of anhydrous oral glucose as prescribed by the ADA, dissolved in 200 ml of water.

Other: Placebo OGTT

Intervention (OGTT plus Baobab fruit extract)

EXPERIMENTAL

The intervention group ingested glucose solution followed by 250 ml of baobab aqueous extract (33.33 g FW).

Other: Baobab fruit aqueous extract

Interventions

Baobab fruit aqueous extract OTHER

After overnight fasting, blood glucose level was assessed through a capillary drop blood, immediately before Oral Glucose Tolerance Test (t0). The intervention group ingested glucose solution followed by 250 ml of baobab aqueous extract (33.33 g FW). Blood glucose level was also measured at 30 (t30), 60 (t60), 90 (t90) and 120 (t120) minutes immediately after intervention, for each participant, in control and intervention groups. Glucometer equipment, strips for glucose meters (One Touch Select Plus) and sterilized lancets (Sarstedt normal 21G) were used to measure blood glucose concentrations, taking due care of safety and asepsis.

Intervention (OGTT plus Baobab fruit extract)

Placebo OGTT OTHER

After overnight fasting, blood glucose level was assessed through a capillary drop blood, immediately before Oral Glucose Tolerance Test (t0). The control group participants ingested glucose solution alone (OGTT) prepared with 75 g of anhydrous oral glucose as prescribed by the ADA, dissolved in 200 ml of water. Blood glucose level was also measured at 30 (t30), 60 (t60), 90 (t90) and 120 (t120) minutes immediately after intervention, for each participant, in control and intervention groups. Glucometer equipment, strips for glucose meters (One Touch Select Plus) and sterilized lancets (Sarstedt normal 21G) were used to measure blood glucose concentrations, taking due care of safety and asepsis.

Placebo (OGTT)

Eligibility Criteria

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

You may qualify if:

• Not currently undergoing lactation or pregnancy,
• To be able to read and sign the informed consent.
• Healthy subjects and a fasting blood glucose \< 126 mg/dl

You may not qualify if:

• Subjects that were less than 8 or more than 10 hours fasting,
• To have symptoms and history of gastrointestinal, hepatic and cardiovascular diseases
• Baobab intolerance or allergy,
• Drug and/or supplement consumption capable of influencing plasma glucose
• Have ingested baobab, water, coffee or alcohol intake and smoked tobacco consumption within 8 hours before the intervention

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Instituto Universitário Egas Moniz

Almada, Monte de Caparica, 2829-511, Portugal

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Margarida Moncada, PhD

  Centro de Investigação Interdisciplinar Egas Moniz, Instituto Universitário Egas Moniz, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 1, 2021
• Study Start: January 2, 2017
• Primary Completion: July 30, 2018
• Study Completion: October 30, 2018
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

PT (1)