Acceptability and tolerability of a Hibiscus sabdariffa L. beverage and effect on biomarkers of pregnant women: Phase I pilot trial

Abstract

Background: Hibiscus sabdariffa L. (HS) is a plant in the Malvaceae family, known as roselle, whose calyces contain compounds with antioxidant and anti-inflammatory properties. Various studies have demonstrated its antihypertensive, antihyperlipidemic, and glycemic control effects. During pregnancy, women also experience metabolic and biochemical changes that allow them to adapt to the development of a new human being. Among these metabolic changes are increased plasma concentrations of glucose and fatty acids, which can serve as substrates for fetal growth. However, if not adequately controlled, they can lead to gestational diabetes and dyslipidemia. One of the main complications of pregnancy is hypertensive disorders, which affect 10% of worldwide pregnancies and are the leading cause of maternal and fetal morbidity and mortality. 

Objective: This work aimed to evaluate the acceptability and tolerability of a Hibiscus sabdariffa beverage and its effect on biomarkers in women in the second trimester of pregnancy. 

Methods: A four-week phase I pilot trial was conducted in women in their second trimester of pregnancy. Participants consumed a daily dose of HS beverage, which provides 9.6 mg of total anthocyanins, and several metabolic parameters were recorded (diastolic and systolic blood pressure, plasma glucose, cholesterol, triglycerides, and creatinine concentrations, as well as urinary protein levels). Measurements were taken before the start of the trial and at the end of the 4 weeks following beverage consumption. 

Results: The protocol for this study was approved by the Research Ethics Committee of the Centro de Desarrollo de Productos Bióticos. Ten women participated in the trial. Diastolic and systolic blood pressure values did not change significantly between the initial and final measurements. Plasma markers also showed no significant differences between the two measurements, although there was a slight decrease in glucose (from 80.5 ± 8.4 to 74.8 ± 9.6 mg/dL) and triglycerides (from 110.7 ± 24.5 to 105.7 ± 14.4 mg/dL). The limitations of this work were the number of participants and the study time, however, as it was a phase I pilot trial, the aim was to identify the acceptability and tolerability of the beverage and to obtain preliminary information regarding the biomarkers to apply them in a study with a larger number of participants over an extended period. 

Novelty: The originality of this work is the use of an HS beverage made from ground calyces, instead of a traditional infusion or extracts, to determine whether its use is feasible during pregnancy, as well as to obtain preliminary information about its effects on blood pressure and biomarkers. This pilot is the first to evaluate a ground-calyx Hibiscus sabdariffa beverage (not an infusion or extract) providing 9.6 mg/day total anthocyanins specifically in second-trimester pregnant women, focusing on acceptability, tolerability, and preliminary cardiometabolic biomarkers.

Conclusion: HS beverage demonstrated acceptability and tolerability. Although the number of women included in this preliminary trial is low, it may be expected to have at least one case of an increase in blood pressure, but none presented these symptoms. The prevention of hypertension in all cases is a promising result. The HS beverage could be evaluated in longer-term clinical trials to confirm the maintenance of blood pressure and biochemical indicators at adequate values for pregnant women according to World Health Organization throughout the pregnancy.

Keywords: Hibiscus sabdariffa, acceptability, tolerability, hypertensive disorders of pregnancy