Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women

Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial

Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Combination product: Placebo; Dietary supplement: Rice Germ

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Azienda di Servizi alla Persona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• obesity (BMI 30-40 kg/m2)
• age 50-65
• menopause
• sedentary women and non-smoking,
• women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
• women who agreed not to take part in any other weight loss program

Exclusion Criteria:

• evidence of heart, kidney or liver disease
• women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
• taking any medications for weight loss
• control of cholesterol and triglycerides for anti-inflammatory purposes
• pregnancy
• lactating
• Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
• antibiotic use in the last three months
• probiotic/prebiotic treatment in the last four weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; an isocaloric wheat germ-based supplement	Combination product: Placebo; An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
Active Comparator: Rice Germ	Dietary supplement: Rice Germ; The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body composition	free fat mass (g), fat mass (g), visceral abdominal tissue (g)	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of amino acid profiles	aspartic acid, glutamic acid, alanine, arginine, asparagine, cysteine, citrulline, phenylalanine, glycine, glutamine, isoleucine, histidine, methylhistidine, methionine, ornithine, serine, tyrosine, threonine, tryptophan, valine (micromol/L)	Baseline and 4 weeks
Change of biochemical metabolic parameters	total serum cholesterol, triacylglycerol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A, apolipoprotein B, glucose, prealbumin, iron, uric acid, creatinine, electrolytes (mg/dl)	Baseline and 4 weeks
Change of biochemical metabolic parameters	total proteins (g/dl)	Baseline and 4 weeks
Change of biochemical metabolic parameters	transaminase alanine aminotransferase, aspartate aminotransferase (IU/L)	Baseline and 4 weeks
Change of biochemical metabolic parameters	gamma glutamyl transferase, lipase and amylase (U/L)	Baseline and 4 weeks
Change of biochemical metabolic parameters	Homocysteine (micromol/L)	Baseline and 4 weeks
Change of biochemical metabolic parameters	Vitamin D and folic acid (ng/mL)	Baseline and 4 weeks
Change of biochemical metabolic parameters	Vitamin B12 (pg/ml)	Baseline and 4 weeks
Change of inflammation markers	C- Reactive protein (mg/dl)	Baseline and 4 weeks
Change of insulin resistance	Homeostasis Model Assessment (HOMA) index	Baseline and 4 weeks
Change of satiating capacity	Haber score (point scale)	Every day for 4 weeks
Change of anthropometric measures	weight (kg)	Baseline and 4 weeks
Change of anthropometric measures	Body mass index (Kg/m2)	Baseline and 4 weeks
Change of anthropometric measures	calf circumference, waist circumference, arm circumference, hip circumference (cm)	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2018
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Body composition; Amino acids; Rice Germ
• Other Study ID Numbers: 1402/22052019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No