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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695418
• Other study ID #: 1402/22052019
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: January 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 27, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

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

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body composition	free fat mass (g), fat mass (g), visceral abdominal tissue (g)	Baseline and 4 weeks
Secondary	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
Secondary	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
Secondary	Change of biochemical metabolic parameters	total proteins (g/dl)	Baseline and 4 weeks
Secondary	Change of biochemical metabolic parameters	transaminase alanine aminotransferase, aspartate aminotransferase (IU/L)	Baseline and 4 weeks
Secondary	Change of biochemical metabolic parameters	gamma glutamyl transferase, lipase and amylase (U/L)	Baseline and 4 weeks
Secondary	Change of biochemical metabolic parameters	Homocysteine (micromol/L)	Baseline and 4 weeks
Secondary	Change of biochemical metabolic parameters	Vitamin D and folic acid (ng/mL)	Baseline and 4 weeks
Secondary	Change of biochemical metabolic parameters	Vitamin B12 (pg/ml)	Baseline and 4 weeks
Secondary	Change of inflammation markers	C- Reactive protein (mg/dl)	Baseline and 4 weeks
Secondary	Change of insulin resistance	Homeostasis Model Assessment (HOMA) index	Baseline and 4 weeks
Secondary	Change of satiating capacity	Haber score (point scale)	Every day for 4 weeks
Secondary	Change of anthropometric measures	weight (kg)	Baseline and 4 weeks
Secondary	Change of anthropometric measures	Body mass index (Kg/m2)	Baseline and 4 weeks
Secondary	Change of anthropometric measures	calf circumference, waist circumference, arm circumference, hip circumference (cm)	Baseline and 4 weeks