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

Sponsor

Azienda di Servizi alla Persona di Pavia (Other)

Overall Status

Completed

CT.gov ID

NCT04695418

Collaborator

(none)

Enrollment

Location

Arms

22.9

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Rice Germ Combination Product: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 28, 2018

Actual Primary Completion Date :

Dec 2, 2019

Actual Study Completion Date :

Dec 27, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of body composition [Baseline and 4 weeks]
free fat mass (g), fat mass (g), visceral abdominal tissue (g)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda di Servizi alla Persona	Pavia		Italy	27100

Sponsors and Collaborators

Azienda di Servizi alla Persona di Pavia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda di Servizi alla Persona di Pavia

ClinicalTrials.gov Identifier:

NCT04695418

Other Study ID Numbers:

1402/22052019

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 5, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda di Servizi alla Persona di Pavia

Rice Germ

Body composition

Amino acids

Study Results

No Results Posted as of Jan 5, 2021